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
8281–8304 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 13, 1987
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT
K872197 · CIG
Sigma Diagnostics, Inc.
Chemistry · 66d
Cleared Aug 13, 1987
EASY ST ANALYZER SYSTEM
K872813 · JJE
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Aug 13, 1987
BIOTROL AST/TGO MONOREACTIF
K872829 · CIT
Biotrol, USA, Inc.
Chemistry · 27d
Cleared Aug 13, 1987
BIOTROL ALT/TGP MONOREACTIF
K872830 · CKA
Biotrol, USA, Inc.
Chemistry · 27d
Cleared Aug 13, 1987
CALCITONIN RIA KIT
K872880 · JKR
Endocrine Associates, Inc.
Chemistry · 23d
Cleared Aug 13, 1987
CARBON DIOXIDE
K872886 · KMS
Catachem, Inc.
Chemistry · 22d
Cleared Aug 10, 1987
ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD
K872391 · DJG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 52d
Cleared Aug 05, 1987
CENTRICELL(TM)
K871290 · JJH
Polysciences, Inc.
Chemistry · 127d
Cleared Aug 05, 1987
CLEARPLAN
K871332 · CEP
Unipath , Ltd.
Chemistry · 124d
Cleared Aug 05, 1987
AMYLASE TEST KIT
K872023 · JFJ
Ciba Corning Diagnostics Corp.
Chemistry · 71d
Cleared Aug 05, 1987
LIPID CONTROL SERUM
K872376 · JJY
Biological Industries
Chemistry · 47d
Cleared Aug 05, 1987
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
K872727 · CEP
Serono Diagnostics, Inc.
Chemistry · 28d
Cleared Aug 05, 1987
BINAX IRMA TOTAL BETA-HCG TEST KIT
K872728 · JHI
Binax, Inc.
Chemistry · 28d
Cleared Aug 03, 1987
MICROMI-CK(TM)
K872598 · JHT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 32d
Cleared Jul 31, 1987
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
K872196 · JJS
American Dade
Chemistry · 53d
Cleared Jul 31, 1987
MICROMEDIC COMBOSTAT LH/FSH KIT
K872309 · CGJ
Micromedic Systems
Chemistry · 45d
Cleared Jul 31, 1987
IMACK-MB(TM)
K872592 · JHT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 30d
Cleared Jul 31, 1987
CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE
K872716 · JGS
Ciba Corning Diagnostics Corp.
Chemistry · 21d
Cleared Jul 31, 1987
WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM
K872792
Millipore Corp.
Chemistry · 17d
Cleared Jul 31, 1987
TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA.
K872897 · JLW
Serono Diagnostics, Inc.
Chemistry · 8d
Cleared Jul 27, 1987
DIABETES RISK DETECTOR
K864544 · JIL
Pearce Clinical Laboratories, Inc.
Chemistry · 250d
Cleared Jul 27, 1987
OVUQUICK SELF-TEST (OVUQUICK
K871726 · CEP
Monoclonal Antibodies, Inc.
Chemistry · 83d
Cleared Jul 27, 1987
EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616
K872320 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Jul 27, 1987
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95
K872322 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 40d