FDA 510(k) Applications for Medical Device Product Code "DIF"
(Drug Mixture Control Materials)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K971534 | BECKMAN | SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL | 05/21/1997 |
| K983709 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 | 10/28/1998 |
| K972819 | BECKMAN INSTRUMENTS, INC. | VIGIL TDM CONTROLS | 08/13/1997 |
| K970666 | BIO-RAD | LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL | 03/10/1997 |
| K033366 | BIO-RAD | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 | 12/12/2003 |
| K052053 | BIO-RAD | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK | 08/09/2005 |
| K012741 | BIO-RAD | LIQUICHEK TDM CONTROL | 09/12/2001 |
| K971691 | BIO-RAD | LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3 | 05/30/1997 |
| K033404 | BIO-RAD | LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) | 12/12/2003 |
| K981590 | BIO-RAD | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON | 06/10/1998 |
| K021415 | BIO-RAD | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 | 05/29/2002 |
| K021414 | BIO-RAD | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 | 05/29/2002 |
| K021411 | BIO-RAD | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 | 05/29/2002 |
| K022707 | BIO-RAD | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 | 08/22/2002 |
| K021384 | BIO-RAD | LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 | 05/29/2002 |
| K042865 | BIO-RAD | LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) | 11/24/2004 |
| K041561 | BIO-RAD | LIQUICHEK WHOLE BLOOD VOLATILES CONTROL | 07/06/2004 |
| K955153 | BIO-RAD | LYPHOCHEK BENZO/TCA CONTROL-SET B | 02/05/1996 |
| K972174 | BIO-RAD | LYPHOCHEK REMEDI CONTROL | 06/24/1997 |
| K980871 | BIO-RAD | LYPHOCHEK WHOLE BLOOD CONTROL | 04/06/1998 |
| K093577 | Bio-Rad Laboratories | LIQUICHEK OPIATE CONTROL | 03/12/2010 |
| K121143 | Bio-Rad Laboratories | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) | 05/18/2012 |
| K050682 | BIO-RAD LABORATORIES, INC. | LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) | 04/29/2005 |
| K033924 | BIO-RAD LABORATORIES, INC. | LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) | 02/03/2004 |
| K120504 | BIO-RAD LABORATORIES, INC. | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK | 03/27/2012 |
| K072721 | BIO-RAD, DIAGNOSTICS GRP. | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC | 12/11/2007 |
| K121122 | BIOCHEMICAL DIAGNOSTIC, INC. | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | 07/03/2012 |
| K153474 | BIOCHEMICAL DIAGNOSTICS, INC | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series | 02/23/2016 |
| K132688 | BIOCHEMICAL DIAGNOSTICS, INC. | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ | 12/16/2013 |
| K063398 | BIONOSTICS, INC. | ESA LEADCARE II LEAD CONTROL | 12/05/2006 |
| K013002 | BIOSITE INCORPORATED | TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 | 10/03/2001 |
| K060788 | BIOSITE INCORPORATED | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | 07/10/2006 |
| K050037 | BIOSITE INCORPORATED | TRIAGE TOX DRUG SCREEN CONTROLS | 03/22/2005 |
| K012999 | BIOSITE INCORPORATED | TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 | 10/03/2001 |
| K965157 | BOEHRINGER MANNHEIM CORP. | CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 | 01/17/1997 |
| K971060 | BOEHRINGER MANNHEIM CORP. | PRECINORM TDM CONTROLS | 07/07/1997 |
| K960244 | CASCO STANDARDS | DOCUMENT TDM ULTRA ASSAYED CONTROL | 03/22/1996 |
| K012907 | CLINICAL CONTROLS | LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL | 09/28/2001 |
| K062191 | DADE BEHRING, INC. | DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 | 08/21/2006 |
| K041666 | DIAGNOSTIC CHEMICALS LTD. | DC-ACETA/SAL CONTROLS | 08/17/2004 |
| K964771 | DYNA-TEK INDUSTRIES | DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 | 02/04/1997 |
| K971058 | MEDICAL ANALYSIS SYSTEMS, INC. | DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404) | 04/08/1997 |
| K032826 | MEDICAL ANALYSIS SYSTEMS, INC. | MAS PAR TDM | 10/09/2003 |
| K982024 | MEDICAL ANALYSIS SYSTEMS, INC. | OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 | 06/29/1998 |
| K983127 | MEDICAL ANALYSIS SYSTEMS, INC. | OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 | 09/14/1998 |
| K961724 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. | U-DOA CONTROLS | 06/03/1996 |
| K040758 | MICROGENICS CORP. | MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT | 05/28/2004 |
| K103656 | Microgenics Corporation | THERMO SCIENTIFIC MAS R DOA TOTAL | 03/24/2011 |
| K980331 | MORE DIAGNOSTICS | IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S | 03/16/1998 |
| K982649 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III | 08/12/1998 |
| K060417 | QUANTIMETRIX CORP. | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL | 03/21/2006 |
| K012319 | RANDOX LABORATORIES, LTD. | RANDOX HUMAN ASSSAYED DRUG CONTROL | 08/24/2001 |
| K962165 | ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS-FP TDM CALIBRATION VERIFICATION TEST SET | 06/26/1996 |
| K983387 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTCUP AND TESTSTIK CONTROLS | 10/09/1998 |
| K964422 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL | 11/25/1996 |
| K080183 | ROCHE DIAGNOSTICS CORP. | CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 | 03/25/2008 |
| K990377 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV | 02/26/1999 |
| K982217 | SC CALIBRATORS & CONTROLS LLC. | AC/AD LINEARITY VERIFIERS | 07/02/1998 |
| K992395 | SERACARE TECHNOLOGY | URINE DRUG SCREENING CONTROL | 08/26/1999 |
| K132174 | TECHNO-PATH MANUFACTURING LTD. | MULTICHEM WBT | 09/20/2013 |
| K080085 | Thermo Fisher Scientific | MAS TOX CONTROL | 04/30/2008 |
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