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
4009–4032 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 04, 1998
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
K983693 · JIT
Dade Behring, Inc.
Chemistry · 14d
Cleared Nov 04, 1998
STRATUS CS TROPONIN I CALIBRATOR
K983722 · JIT
Dade Behring, Inc.
Chemistry · 14d
Cleared Nov 03, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K983513 · JJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Oct 28, 1998
CLEARPLAN EASY FERTILITY MONITOR
K981207 · NGE
Unipath , Ltd.
Chemistry · 209d
Cleared Oct 27, 1998
CHEMSTRIP 101 URINE ANALYZER
K983510 · KQO
Boehringer Mannheim Corp.
Chemistry · 20d
Cleared Oct 23, 1998
MG
K981791 · JGJ
Abbott Laboratories
Chemistry · 155d
Cleared Oct 21, 1998
GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE
K982998 · JKA
Greiner Meditech, Inc.
Chemistry · 55d
Cleared Oct 21, 1998
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
K983416 · JGJ
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Oct 16, 1998
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
K980907 · LPS
Axis Biochemicals, Asa
Chemistry · 220d
Cleared Oct 16, 1998
GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE
K982999 · JKA
Greiner Meditech, Inc.
Chemistry · 50d
Cleared Oct 09, 1998
ONTRAK TESTCUP AND TESTSTIK CONTROLS
K983387 · DIF
Roche Diagnostic Systems, Inc.
Chemistry · 14d
Cleared Oct 09, 1998
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC
K983492 · JJY
Boehringer Mannheim Corp.
Chemistry · 4d
Cleared Oct 07, 1998
HEALTH CHECK URI-TEST PROTEIN IN URINE
K972960 · JIR
Tcpi, Inc.
Chemistry · 422d
Cleared Oct 07, 1998
HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI...
K974854 · JHO
Morax
Chemistry · 282d
Cleared Oct 07, 1998
MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST
K982679 · DDR
Spectral Diagnostics, Inc.
Chemistry · 68d
Cleared Oct 01, 1998
IMX HOMOCYSTEINE
K980812 · DFC
Axis Biochemicals, Asa
Chemistry · 212d
Cleared Oct 01, 1998
UPRO
K981295 · JGQ
Abbott Laboratories
Chemistry · 175d
Cleared Oct 01, 1998
CHOLESTRON PRO II CHOLESTEROL TEST
K981345 · CHH
Lifestream Diagnostics, Inc.
Chemistry · 170d
Cleared Oct 01, 1998
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
K982848 · MRR
Roche Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Sep 28, 1998
AST
K983131 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Sep 24, 1998
FREE T4 MICROWELL EIA, MODEL #7019
K982954 · CEC
Biomerica, Inc.
Chemistry · 31d
Cleared Sep 23, 1998
NBIL
K983134 · MQM
Abbott Laboratories
Chemistry · 15d
Cleared Sep 22, 1998
JM-102 JAUNDICE METER
K972309 · MQM
Air-Shields, Inc.
Chemistry · 459d
Cleared Sep 22, 1998
WAKO DIRECT LDL-C
K982271 · MRR
Wako Chemicals USA, Inc.
Chemistry · 85d