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
5665–5688 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 16, 1993
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
K935136 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Dec 16, 1993
TOTAL PROTEIN TEST (TPRO)
K935174 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Dec 16, 1993
LACTATE DEHYDROGENASE (LD)
K935175 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Dec 16, 1993
IRON TEST
K935176 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Dec 16, 1993
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Dec 10, 1993
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
K932766 · LBR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 185d
Cleared Dec 10, 1993
SIGMA WASH CONCENTRATE SOLUTION
K933703 · JJE
Sigma Chemical Co.
Chemistry · 134d
Cleared Dec 10, 1993
CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY
K934562 · CDZ
Ciba Corning Diagnostics Corp.
Chemistry · 85d
Cleared Dec 10, 1993
IMMUNLITE INTACT PTH
K934760 · CEW
Diagnostic Products Corp.
Chemistry · 67d
Cleared Dec 09, 1993
QUANTIMETRIX BLOOD GLUCOSE CONTROLS
K932623 · JIX
Quantimetrix Corp.
Chemistry · 191d
Cleared Dec 09, 1993
SIGMA CO2 ACID REAGENT
K933692 · JFL
Sigma Chemical Co.
Chemistry · 133d
Cleared Dec 09, 1993
I-STAT CONTROL LEVELS 1,2,3
K934641 · JJR
I-Stat Corp.
Chemistry · 79d
Cleared Dec 09, 1993
SPINPRO HDL PRECIPITATING REAGENT
K934961 · LBR
Merchant House Scientific
Chemistry · 55d
Cleared Dec 09, 1993
EMDS ALKANINE PHOSPHATASE (ALP) TEST
K935182 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Dec 09, 1993
EMDS MAGNESIUM (MG) TEST
K935183 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Dec 07, 1993
APEC GLUCOSE ANALYZER
K931196 · CGA
Apec, Inc.
Chemistry · 273d
Cleared Dec 07, 1993
SPINPRO HDL PRECIPITATING REAGENT
K934801 · LBR
Merchant House Scientific
Chemistry · 61d
Cleared Dec 07, 1993
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
K934898 · CGA
Heraeus Kulzer, Inc.
Chemistry · 55d
Cleared Dec 07, 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
K934900 · CFR
Heraeus Kulzer, Inc.
Chemistry · 55d
Cleared Dec 03, 1993
COBAS CORE TSH EIA
K930776 · JLW
Roche Diagnostic Systems, Inc.
Chemistry · 290d
Cleared Dec 03, 1993
COBAS(R) CORE T3 EIA
K932608 · CDP
Roche Diagnostic Systems, Inc.
Chemistry · 189d
Cleared Dec 03, 1993
CIBA CORNING ACS ESTRADIOL IMMUNOASSAY
K932715 · CHP
Ciba Corning Diagnostics Corp.
Chemistry · 182d
Cleared Dec 03, 1993
CIBA CORNING ACS FREE T3 IMMUNOASSAY
K932747 · CDP
Ciba Corning Diagnostics Corp.
Chemistry · 178d
Cleared Dec 03, 1993
COCAINE METABOLITE EIA ASSAY MODIFICATION
K935016 · DIO
Diagnostic Reagents, Inc.
Chemistry · 46d