FDA 510(k) Searchable Database - Search 175,000+ Clearances

Cleared Aug 27, 2003

D-10 HEMOGLOBIN A1C

K031043 · LCP

Bio-Rad Laboratories, Inc.

Chemistry · 148d

Cleared Aug 25, 2003

LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER...

K031921 · JJY

Cliniqa Corporation

Chemistry · 63d

Cleared Aug 25, 2003

VISUALINE METHADONE DIPSTRIPTEST

K023856 · DJR

Sun Biomedical Laboratories, Inc.

Chemistry · 279d

Cleared Aug 22, 2003

ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300

K030860 · KLI

Monobind

Chemistry · 157d

Cleared Aug 21, 2003

ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID

K032377 · KHS

Roche Diagnostics Corp.

Chemistry · 20d

Cleared Aug 21, 2003

OLYMPUS PREALBUMIN CALIBRATOR, ODR3029

K032285 · JIT

Olympus America, Inc.

Chemistry · 28d

Cleared Aug 20, 2003

ELECYS SHBG CALCHECK

K031698 · JJX

Roche Diagnostics Corp.

Chemistry · 79d

Cleared Aug 19, 2003

MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL

K032335 · JJY

Medical Analysis Systems, Inc.

Chemistry · 21d

Cleared Aug 18, 2003

MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

K032287 · JIX

Beckman Coulter, Inc.

Chemistry · 25d

Cleared Aug 18, 2003

FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT

K030730 · CDZ

Diagnostics Biochem Canada, Inc.

Chemistry · 161d

Cleared Aug 14, 2003

AUSAM TOTAL ALBUMIN ASSAY

K013643 · JIQ

Ausam Biotecthnologies, Inc.

Chemistry · 647d

Cleared Aug 13, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS

K032296 · JIS

Ortho-Clinical Diagnostics, Inc.

Chemistry · 19d

Cleared Aug 08, 2003

RANDOX LIQUID PROTEIN CALIBRATOR

K031608 · JIX

Randox Laboratories, Ltd.

Chemistry · 78d

Cleared Aug 08, 2003

IMMUNICON CELLSAVE PRESERVATIVE TUBE

K030596 · JKA

Immunicon Corp.

Chemistry · 164d

Cleared Aug 07, 2003

VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK,...

K031924 · JIT

Ortho-Clinical Diagnostics

Chemistry · 45d

Cleared Aug 06, 2003

TOX AMMONIA CALIBRATOR

K031683 · JIX

Bayer Healthcare, LLC

Chemistry · 68d

Cleared Aug 06, 2003

LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY...

K031577 · JJY

Cliniqa Corporation

Chemistry · 78d

Cleared Aug 06, 2003

HEMOGLOBIN A1C REAGENT SET

K031539 · LCP

Pointe Scientific, Inc.,

Chemistry · 82d

Cleared Aug 05, 2003

TINA-QUANT CRP (LATEX)

K032336 · DCN

Roche Diagnostics Corp.

Chemistry · 7d

Cleared Aug 05, 2003

PRECISET DAT PLUS I CALIBRATORS

K031775 · DKB

Roche Diagnostics Corp.

Chemistry · 56d

Cleared Aug 05, 2003

ELECSYS SHBG IMMUNOASSAY

K031717 · CDZ

Roche Diagnostics Corp.

Chemistry · 63d

Cleared Aug 05, 2003

ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS

K031472 · CGA

Lifescan, Inc.

Chemistry · 88d

Cleared Aug 04, 2003

GLUCOLEADER VALUE

K023279 · NBW

Hmd Biomedical, Inc.

Chemistry · 307d

Cleared Jul 31, 2003

NICHOLS ADVANTAGE ALDOSTERONE ASSAY

K032188 · CJM

Nichols Institute Diagnostics

Chemistry · 14d