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
4825–4848 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 28, 1996
DSL ACTIVE I-HCG ELISA
K961911 · JHI
Diagnostic Systems Laboratories, Inc.
Chemistry · 42d
Cleared Jun 26, 1996
VITROS SPECIALTY DILUENT
K962235 · JJE
Johnson & Johnson Clinical...
Chemistry · 15d
Cleared Jun 25, 1996
CIBA CORNING 400 SYSTEM
K961657 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 56d
Cleared Jun 24, 1996
BIODATA TESTOSTERONE MAIA KIT
K955102 · CDZ
Biochem Immunosystems (U.S.), Inc.
Chemistry · 229d
Cleared Jun 24, 1996
SURE CHECK PREGNANCY TEST
K961965 · LCX
Chembio Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jun 24, 1996
CIBA CORNING 348 SYSTEM
K962021 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 32d
Cleared Jun 21, 1996
AMYLASE (ETHYLIDENE PNGPG7) KIT
K953211 · CIJ
Randox Laboratories, Ltd.
Chemistry · 347d
Cleared Jun 21, 1996
UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE
K954514 · KQO
Sciteck Diagnostics, Inc.
Chemistry · 267d
Cleared Jun 21, 1996
CALIBRATION SERUM LEVEL 1 & 2
K955489 · JIX
Randox Laboratories, Ltd.
Chemistry · 207d
Cleared Jun 21, 1996
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
K961282 · CFR
Diagnostic Chemicals , Ltd.
Chemistry · 79d
Cleared Jun 21, 1996
EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER
K961326 · CEM
Medica Corp.
Chemistry · 74d
Cleared Jun 21, 1996
EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM
K961337 · CGA
Medisense, Inc.
Chemistry · 74d
Cleared Jun 21, 1996
IMPACT
K961694 · JQW
Matrix Technologies Corp.
Chemistry · 51d
Cleared Jun 21, 1996
ACS LH2 IMMUNOASSAY
K962041 · CEP
Ciba Corning Diagnostics Corp.
Chemistry · 24d
Cleared Jun 21, 1996
ACS CKMB II IMMUNOASSAY
K962126 · JHS
Ciba Corning Diagnostics Corp.
Chemistry · 18d
Cleared Jun 18, 1996
DIA SCREEN 10 WAY REAGENT STRIPS
K961375 · JIL
Genesis Labs, Inc.
Chemistry · 70d
Cleared Jun 17, 1996
ACS FRT4 IMMUNOASSAY
K961510 · JJX
Ciba Corning Diagnostics Corp.
Chemistry · 59d
Cleared Jun 14, 1996
FIRST CHOICE GLUCOSE URINE TEST STRIPS
K953661 · JIL
Polymer Technology Intl.
Chemistry · 312d
Cleared Jun 14, 1996
FIRST CHOICE KETONES URINE TEST STRIPS
K953662 · JIN
Polymer Technology Intl.
Chemistry · 312d
Cleared Jun 14, 1996
QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)
K961354 · JJS
Radiometer America, Inc.
Chemistry · 67d
Cleared Jun 14, 1996
MULTICHECK
K961355 · JJS
Radiometer America, Inc.
Chemistry · 67d
Cleared Jun 14, 1996
ELECSYS 2010 ANALYZER
K961481 · JJE
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Jun 13, 1996
HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT
K933722 · CDT
Horizon Diagnostics, Inc.
Chemistry · 1046d
Cleared Jun 13, 1996
ELECSYS T4 ASSAY
K961490 · CDX
Boehringer Mannheim Corp.
Chemistry · 56d