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

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
3553–3576 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 05, 2000
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
K001607 · CDP
Repromedix Corp.
Chemistry · 134d
Cleared Oct 05, 2000
REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
K001606 · JLW
Repromedix Corp.
Chemistry · 134d
Cleared Oct 05, 2000
REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
K001603 · KLI
Repromedix Corp.
Chemistry · 134d
Cleared Oct 05, 2000
I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
K001387 · CGA
I-Stat Corp.
Chemistry · 156d
Cleared Oct 02, 2000
BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
K002294 · CDZ
Biocheck, Inc.
Chemistry · 67d
Cleared Sep 26, 2000
ATAC PAK ALP REAGENT KIT
K002285 · CJE
Elan Diagnostics
Chemistry · 62d
Cleared Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
K002866 · JJS
Bio-Rad
Chemistry · 12d
Cleared Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
K002865 · JJS
Bio-Rad
Chemistry · 12d
Cleared Sep 18, 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD...
K002540 · JJX
Bionostics, Inc.
Chemistry · 33d
Cleared Sep 15, 2000
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
K002694 · CDQ
Diagnostic Chemicals , Ltd.
Chemistry · 17d
Cleared Sep 13, 2000
ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
K002290 · CHL
Radiometer Medical A/S
Chemistry · 48d
Cleared Sep 05, 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907 · CGA
Roche Diagnostics Corp.
Chemistry · 75d
Cleared Aug 31, 2000
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
K002460 · JJY
Bio-Rad
Chemistry · 21d
Cleared Aug 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
K002536 · JJS
Bio-Rad
Chemistry · 14d
Cleared Aug 30, 2000
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513
K002535 · JJS
Bio-Rad
Chemistry · 14d
Cleared Aug 23, 2000
CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
K001943 · NAO
Sangui Biotech, Inc.
Chemistry · 58d
Cleared Aug 22, 2000
DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3
K002174 · JJY
Casco-Nerl Diagnostics Corporation...
Chemistry · 34d
Cleared Aug 22, 2000
ELECSYS HCG TEST SYSTEM
K002148 · DHA
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Aug 22, 2000
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER,...
K001935 · CDZ
Beckman Coulter, Inc.
Chemistry · 57d
Cleared Aug 21, 2000
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
K002120 · JJS
Bio-Rad
Chemistry · 39d
Cleared Aug 21, 2000
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL...
K001411 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 109d
Cleared Aug 14, 2000
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
K001810 · JIR
Flexsite Diagnostics, Inc.
Chemistry · 60d
Cleared Aug 10, 2000
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P,...
K001403 · CFR
Sigma Diagnostics, Inc.
Chemistry · 99d
Cleared Aug 07, 2000
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
K002196 · JJY
Bio-Rad
Chemistry · 18d