FDA 510(k) Applications Submitted by CHARLES YU
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020716 |
03/05/2002 |
RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS) |
RAPID DIAGNOSTICS, INC. |
| K960117 |
01/11/1996 |
PLATFORM ONESTEP PREGNANCY HOME TEST |
SYNTRON BIORESEARCH, INC. |
| K981770 |
05/19/1998 |
RAPIDHCG PREGNANCY TEST |
RAPID DIAGNOSTICS, INC. |
| K071971 |
07/17/2007 |
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL |
DIAZYME LABORATORIES |
| K072270 |
08/15/2007 |
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) |
DIAZYME LABORATORIES |
| K963341 |
08/26/1996 |
MIDSTREAM ONESTEP PREGNANCY HOME TEST |
SYNTRON BIORESEARCH, INC. |
| K072395 |
08/27/2007 |
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS |
DIAZYME LABORATORIES |
| K983113 |
09/04/1998 |
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT |
SYNTRON BIORESEARCH, INC. |
| K072523 |
09/07/2007 |
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS |
GENERAL ATOMICS |
| K073488 |
10/22/2007 |
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX |
DIAZYME LABORATORIES |
| K023252 |
09/30/2002 |
RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 |
ICN BIOMEDICALS, INC. |
| K003809 |
12/08/2000 |
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS |
RAPID DIAGNOSTICS, INC. |
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