Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
1969–1992 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 26, 2008
S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
K072142 · CKF
Alfa Wassermann Diagnostic...
Chemistry · 329d
Cleared Jun 25, 2008
SENTINEL PLASMAPROTEINS CAL 3X
K081533 · JIX
SENTINEL CH. SpA
Chemistry · 23d
Cleared Jun 24, 2008
S-TEST CA
K072356 · CJY
Alfa Wassermann Diagnostic...
Chemistry · 307d
Cleared Jun 24, 2008
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
K072141 · CEO
Alfa Wassermann Diagnostic...
Chemistry · 327d
Cleared Jun 24, 2008
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
K072140 · CFR
Alfa Wassermann Diagnostic...
Chemistry · 327d
Cleared Jun 23, 2008
CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
K081144 · NBW
Taidoc Technology Corporation
Chemistry · 62d
Cleared Jun 20, 2008
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C...
K080811 · NDY
Roche Diagnostics Corp.
Chemistry · 88d
Cleared Jun 19, 2008
MULTIGENT CREATININE (ENZYMATIC) ASSAY
K073634 · JFY
SENTINEL CH. SpA
Chemistry · 176d
Cleared Jun 13, 2008
ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM
K073416 · CGA
Arkray Factory USA, Inc.
Chemistry · 193d
Cleared Jun 09, 2008
ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
K081318 · NBW
Lifescan, Inc.
Chemistry · 28d
Cleared Jun 09, 2008
CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K080014 · NBW
Taidoc Technology Corporation
Chemistry · 158d
Cleared Jun 06, 2008
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
K080384 · NDY
The Binding Site, Ltd.
Chemistry · 114d
Cleared Jun 06, 2008
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
K080269 · NBC
Biosite Incorporated
Chemistry · 126d
Cleared Jun 02, 2008
CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3
K080973 · JJY
Cliniqa Corporation
Chemistry · 59d
Cleared May 29, 2008
UREA/BUN, SCAL, NORTROL, ABTROL
K073295 · CDQ
Thermofisher Scientific OY
Chemistry · 188d
Cleared May 23, 2008
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared May 23, 2008
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF...
K081074 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared May 23, 2008
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
K080618 · LCP
Jas Diagnostics, Inc.
Chemistry · 79d
Cleared May 23, 2008
URIC ACID (AOX), SCAL, NORTROL, ABTROL
K073612 · JIX
Thermofisher Scientific OY
Chemistry · 154d
Cleared May 16, 2008
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT...
K080578 · NBC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 74d
Cleared May 15, 2008
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
K080662 · NDY
Genzyme Corporation
Chemistry · 66d
Cleared May 12, 2008
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
K080607 · JIX
Roche Diagnostics Corp.
Chemistry · 69d
Cleared May 08, 2008
TC MATRIX CLINICAL CHEMISTRY ANALYZER
K073370 · JJE
Teco Diagnostics
Chemistry · 160d
Cleared May 07, 2008
ESA BIOSCIENCES INC. VITAMIN D HPLC TEST
K072536 · MRG
Esa Biosciences, Inc.
Chemistry · 243d