FDA 510(k) Applications Submitted by MARIA ZEBALLOS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040277 |
02/05/2004 |
LIQUICHEK CARDIAC MARKER CONTROL LT |
BIO-RAD LABORATORIES, INC. |
| K050536 |
03/02/2005 |
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL |
BIO-RAD |
| K020878 |
03/18/2002 |
LYPHOCHEK HEMOSTASIS, MODELS 798, 799 |
BIO-RAD |
| K021498 |
05/09/2002 |
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL |
BIO-RAD |
| K071319 |
05/10/2007 |
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 |
BIO-RAD, DIAGNOSTICS GRP. |
| K041561 |
06/10/2004 |
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL |
BIO-RAD |
| K071675 |
06/19/2007 |
LIQUICHEK TUMOR MARKER CONTROL |
Bio-Rad Laboratories |
| K022041 |
06/24/2002 |
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 |
BIO-RAD LABORATORIES, INC. |
| K032017 |
06/30/2003 |
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 |
BIO-RAD |
| K012513 |
08/06/2001 |
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 |
BIO-RAD |
| K012656 |
08/13/2001 |
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 |
BIO-RAD |
| K012722 |
08/15/2001 |
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 |
BIO-RAD |
| K012741 |
08/16/2001 |
LIQUICHEK TDM CONTROL |
BIO-RAD |
| K032611 |
08/25/2003 |
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 |
BIO-RAD |
| K042335 |
08/30/2004 |
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 |
BIO-RAD LABORATORIES, INC. |
| K042336 |
08/30/2004 |
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK |
BIO-RAD LABORATORIES, INC. |
| K022991 |
09/09/2002 |
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 |
BIO-RAD |
| K042446 |
09/09/2004 |
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS |
BIO-RAD LABORATORIES, INC. |
| K052838 |
10/07/2005 |
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 |
BIO-RAD |
| K033366 |
10/21/2003 |
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 |
BIO-RAD |
| K033387 |
10/23/2003 |
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 |
BIO-RAD |
| K033404 |
10/24/2003 |
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) |
BIO-RAD |
| K073080 |
10/31/2007 |
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 |
Bio-Rad Laboratories |
| K043208 |
11/19/2004 |
LIQUID ASSAYED MULTIQUAL CONTROL |
BIO-RAD |
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