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
7033–7056 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 29, 1990
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072 · KLI
Kallestad Diag, A Div. of Erbamont, Inc.
Chemistry · 97d
Cleared Mar 29, 1990
COULTER CHOLESTEROL REAGENT
K897162 · CHH
Coulter Electronics, Inc.
Chemistry · 91d
Cleared Mar 29, 1990
FREE T4 IMMUNOASSAY KIT
K900060 · CEC
Advanced Magnetics, Inc.
Chemistry · 85d
Cleared Mar 29, 1990
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
K900850 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Mar 29, 1990
ELITECH GAMMA GT TEST KIT
K901090 · JPZ
Elite Technology, Inc.
Chemistry · 22d
Cleared Mar 29, 1990
MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD
K901113 · JIS
Verichem Laboratories, Inc.
Chemistry · 22d
Cleared Mar 29, 1990
TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE
K901122 · CFR
Technicon Instruments Corp.
Chemistry · 17d
Cleared Mar 29, 1990
COULTER MAGNESIUM REAGENT
K901265 · JGJ
Coulter Corp.
Chemistry · 13d
Cleared Mar 27, 1990
CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE
K897177 · JIX
Nova Biomedical Corp.
Chemistry · 90d
Cleared Mar 23, 1990
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K900806 · JHS
Baxter Healthcare Corp
Chemistry · 30d
Cleared Mar 23, 1990
PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT
K901104 · CIT
Baxter Healthcare Corp
Chemistry · 15d
Cleared Mar 23, 1990
PARAMAX ALANINE AMINOTRANSFERASE REAGENT
K901105 · CKA
Baxter Healthcare Corp
Chemistry · 15d
Cleared Mar 19, 1990
LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES
K893740 · MRR
Reference Diagnostics, Inc.
Chemistry · 306d
Cleared Mar 19, 1990
SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX
K897176 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 82d
Cleared Mar 19, 1990
IRON LIQUID STABLE REAGENT
K900902 · JIY
Medical Analysis Systems, Inc.
Chemistry · 20d
Cleared Mar 15, 1990
THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT
K897144 · KLI
Medix Biotech, Inc.
Chemistry · 78d
Cleared Mar 15, 1990
OLYMPUS DIRECT BILIRUBIN
K897175 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Mar 15, 1990
VENOJECT II BLOOD COLLECTION TUBES
K900309 · JKA
Terumo Medical Corp.
Chemistry · 52d
Cleared Mar 15, 1990
ENZYMUN TEST(R) FSH
K900763 · CGJ
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Mar 09, 1990
AIA-PACK T4
K896982 · KLI
Tosoh Corp.
Chemistry · 80d
Cleared Mar 09, 1990
TOSOH AIA-PACK T3
K897001 · CDP
Tosoh Corp.
Chemistry · 81d
Cleared Mar 09, 1990
ROCHE STANDARDS FOR THE COBAS ISE MODULE
K897071 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 77d
Cleared Mar 09, 1990
AFFINITY(TM) HTSH(TM)
K897138 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 72d
Cleared Mar 09, 1990
COULTER TRIGLYCERIDES GPO REAGENT
K897159 · CDT
Coulter Electronics, Inc.
Chemistry · 71d