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
8977–9000 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 24, 1986
ULTROSPEC K KINETICS SPECTROPHOTOMETER
K861194 · JJQ
Lkb Instruments, Inc.
Chemistry · 24d
Cleared Apr 24, 1986
GLUCOSE OXIDASE PROCEDURE
K861204 · CGA
Data Medical Associates, Inc.
Chemistry · 24d
Cleared Apr 24, 1986
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
K861221 · JJX
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Apr 24, 1986
GLUCOSE (HEXOKINASE) REAGENT SET
K861311 · CFR
Sterling Diagnostics, Inc.
Chemistry · 16d
Cleared Apr 24, 1986
MMS T4 RIA KIT
K861320 · CDX
Micromedic Systems
Chemistry · 16d
Cleared Apr 24, 1986
BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET
K861413 · CIG
Medical Analysis Systems, Inc.
Chemistry · 9d
Cleared Apr 21, 1986
MICRO-ELISA HLH TEST KIT MONOCLONAL
K860333 · CEP
Bioclinical Systems, Inc.
Chemistry · 82d
Cleared Apr 21, 1986
VISI-CHECK HLH TEST MONOCLONAL
K860334 · CEP
Bioclinical Systems, Inc.
Chemistry · 82d
Cleared Apr 21, 1986
MUREX (TM), SUDS (TM), HCG ASSAY
K860451 · LCX
Murex Corp.
Chemistry · 75d
Cleared Apr 21, 1986
BLOOD UREA NITROGEN (BUN) TESTCARD
K860543 · CDS
Ilex Corp.
Chemistry · 67d
Cleared Apr 21, 1986
IONIZED CALCIUM AND BLOOD PH TESTCARDS
K860639 · JFP
Ilex Corp.
Chemistry · 60d
Cleared Apr 21, 1986
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
K860726 · LFR
Trace Scientific , Ltd.
Chemistry · 54d
Cleared Apr 21, 1986
VISION SGPT (ALT)
K861002 · CKA
Abbott Laboratories
Chemistry · 34d
Cleared Apr 21, 1986
BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02
K861094 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 28d
Cleared Apr 21, 1986
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04
K861095 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 28d
Cleared Apr 17, 1986
ES600 IMMUNOASSAY SYSTEM
K860647 · JJE
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Apr 17, 1986
HITACHI 736
K860748 · JJE
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Apr 16, 1986
ENZYMATIC URIC ACID REAGENT
K860732 · KNK
Trace Scientific , Ltd.
Chemistry · 49d
Cleared Apr 14, 1986
DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R)
K860747 · JQC
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 46d
Cleared Apr 11, 1986
ANSWER PLUS AT HOME PREGNANCY TEST
K860090 · LCX
Armkel, LLC
Chemistry · 91d
Cleared Apr 11, 1986
MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
K860367 · JGF
Alpkem Corp.
Chemistry · 67d
Cleared Apr 11, 1986
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY
K860422 · KHQ
American Dade
Chemistry · 66d
Cleared Apr 11, 1986
AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT
K860663 · JHY
Amresco, Inc.
Chemistry · 46d
Cleared Apr 11, 1986
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL)
K860717 · CHH
Trace Scientific , Ltd.
Chemistry · 44d