FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11017–11040 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 01, 1982
ULTRACHEM T-BILI, #64971
K821462 · CIG
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Jun 01, 1982
ULTRAZYME PLUS LDH, #64950,65038&65039
K821466 · CFJ
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Jun 01, 1982
ULTRAZYME PLUS GOT, #64953,65033&65034
K821467 · CIT
Emd Chemicals, Inc.
Chemistry · 14d
Cleared Jun 01, 1982
VERSACHEM ANALYZER
K821561 · JJQ
Emd Chemicals, Inc.
Chemistry · 7d
Cleared May 28, 1982
QUANTIMUNE HLH RIA
K821346 · CEP
Bio-Rad
Chemistry · 23d
Cleared May 28, 1982
BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.
K821347 · LCA
Bioclinical Corp.
Chemistry · 23d
Cleared May 28, 1982
ENZYMUNE-TEST INSULIN
K821374 · CFP
Icl Scientific
Chemistry · 18d
Cleared May 28, 1982
CHEMISTRY CONTROL/STANDARD
K821382 · JJY
Medical Analysis Systems, Inc.
Chemistry · 18d
Cleared May 28, 1982
DURAZYME CPK
K821452
American Monitor Corp.
Chemistry · 14d
Cleared May 28, 1982
ULTRAZYME PLUS AMYL #65031&64982
K821459 · JFJ
Emd Chemicals, Inc.
Chemistry · 10d
Cleared May 24, 1982
MICROLYTE
K820541 · JJF
Kone Instruments, Inc.
Chemistry · 83d
Cleared May 24, 1982
SPIN CHEM REAGENTS & STANDARDS
K821184 · JIY
Smithkline Diagnostics, Inc.
Chemistry · 27d
Cleared May 24, 1982
PROLACTIN (125-I) RADIOIMMUNOASSAY KIT
K821305 · CFT
Bd Becton Dickinson Vacutainer...
Chemistry · 20d
Cleared May 24, 1982
DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM
K821315 · CDT
The Dow Chemical Co.
Chemistry · 20d
Cleared May 21, 1982
URIC ACID REAGENT SET(ENZYMATIC
K821214 · KNK
Omega Medical Electronics
Chemistry · 24d
Cleared May 21, 1982
ALBUMIN REAGENT
K821225 · CIX
Hi Chem, Inc.
Chemistry · 24d
Cleared May 21, 1982
RIAGEN B-HCG RIA
K821234 · JHI
Biogenex Laboratories
Chemistry · 23d
Cleared May 21, 1982
LIQUID-STAT LIQUID ENZYME REAGENT
K821240 · CGS
Beckman Instruments, Inc.
Chemistry · 22d
Cleared May 21, 1982
RESPONSE LIQUID LIGAND ASSAY SERUM
K821242 · JJY
Beckman Instruments, Inc.
Chemistry · 22d
Cleared May 21, 1982
ACCUDEX REAGENT STRIPS
K821247 · CGA
Miles Laboratories, Inc.
Chemistry · 22d
Cleared May 14, 1982
STRATUS TDM CONTROL, LEVELS I,II,III
K820296 · DIF
American Dade
Chemistry · 99d
Cleared May 14, 1982
8700 CLINICAL CHEM. ANALYZER
K820888 · JJE
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared May 14, 1982
I-DHEA-SULFATE RIA KIT 125
K821145 · JKC
Nuclear Medical Systems, Inc.
Chemistry · 23d
Cleared May 14, 1982
URICASE (U.V.) URIC ACID
K821167 · CDO
Syn-Kit, Inc.
Chemistry · 17d