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
6193–6216 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 10, 1992
OLYMPUS UREA NITROGEN (BUN) REAGENT
K922597 · CDQ
Olympus Corp.
Chemistry · 38d
Cleared Jul 10, 1992
CORTISOL CHEMILUMINESCENCE ASSAY
K922676 · CGR
Nichols Institute
Chemistry · 36d
Cleared Jul 10, 1992
KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA
K922736 · JLW
Eastman Kodak Company
Chemistry · 32d
Cleared Jul 09, 1992
SINGLE-STEP PREGNANCY, HCG TEST
K922290 · JHI
American Medical Products, Inc.
Chemistry · 55d
Cleared Jul 09, 1992
ROCHE REAGENT FOR URIC ACID--MODIFICATION
K922762 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Jul 07, 1992
DADE URINE CHEMISTRY CONTROL LEVELS I AND II
K920636 · JJY
Baxter Diagnostics, Inc.
Chemistry · 146d
Cleared Jul 07, 1992
THYROXINE (T4) COATED TUBE RIA
K921935 · CDX
Monobind
Chemistry · 74d
Cleared Jul 02, 1992
ELISA TUBE TSH TEST
K921958 · JLW
Bio Clinic Co.
Chemistry · 66d
Cleared Jul 02, 1992
OLYMPUS TRIGLYCERIDE REAGENT
K922229 · CDT
Olympus Corp.
Chemistry · 51d
Cleared Jun 30, 1992
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
K921661 · JJE
Boehringer Mannheim Corp.
Chemistry · 84d
Cleared Jun 30, 1992
RNA MEDICAL'S EQUIL 55
K922357 · JJS
Bionostics, Inc.
Chemistry · 42d
Cleared Jun 29, 1992
TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093
K921700 · JLW
Medix Biotech, Inc.
Chemistry · 82d
Cleared Jun 26, 1992
RNA MEDICAL TONOMETER
K922386 · LCH
Bionostics, Inc.
Chemistry · 37d
Cleared Jun 25, 1992
MILENIA FOLIC ACID
K921614 · CGN
Diagnostic Products Corp.
Chemistry · 80d
Cleared Jun 25, 1992
OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER
K922220 · JJE
Olympus Corp.
Chemistry · 44d
Cleared Jun 25, 1992
OLYMPUS GGT REAGENT
K922230 · JQB
Olympus Corp.
Chemistry · 44d
Cleared Jun 24, 1992
THYROXINE (FPIA) KIT
K921904 · KLI
Tudor Laboratories, Inc.
Chemistry · 64d
Cleared Jun 24, 1992
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE
K922612 · CHH
Cholestech Corp.
Chemistry · 22d
Cleared Jun 19, 1992
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024
K920927 · JJY
Helena Laboratories
Chemistry · 112d
Cleared Jun 18, 1992
VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY
K921816 · JLW
Biomerieux Vitek, Inc.
Chemistry · 64d
Cleared Jun 16, 1992
CEDIA RED BLOOD CELL FOLATE REAGENT PACK
K921689 · CGN
Microgenics Corp.
Chemistry · 69d
Cleared Jun 16, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921746 · CGJ
Biomerieux Vitek, Inc.
Chemistry · 64d
Cleared Jun 16, 1992
ROCHE CALIBRATOR SERUM
K922043 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Jun 10, 1992
OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER
K920942 · JJG
Olympus Corp.
Chemistry · 104d