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
6457–6480 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 18, 1991
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28
K913707 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Sep 13, 1991
CONTROL AND LINEARITY
K910881 · DKB
Gds Diagnostics
Chemistry · 196d
Cleared Sep 13, 1991
TDM I LINEARITY TEST SET
K913309 · DIF
Casco Standards
Chemistry · 50d
Cleared Sep 13, 1991
URINARY/CSF PROTEIN
K913615 · JGQ
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared Sep 11, 1991
IMX SELECT ANALYZER
K912368 · JJQ
Abbott Laboratories
Chemistry · 105d
Cleared Sep 11, 1991
NOVA 13 ANALYZER
K912561 · CGZ
Nova Biomedical Corp.
Chemistry · 92d
Cleared Sep 11, 1991
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
K912806 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Sep 11, 1991
OPUS(R) PLUS ANALYZER
K913295 · JJQ
Pb Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Sep 11, 1991
CHOLINESTERASE LINEARITY CONTROL
K913496 · JJX
Creative Laboratory Products, Inc.
Chemistry · 36d
Cleared Sep 11, 1991
AMYLASE REAGENT (PROCEDURE 577)
K913858 · JFJ
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Sep 10, 1991
FIRST CHOICE(TM)
K912732 · CGA
Polymer Technology Corp.
Chemistry · 82d
Cleared Sep 10, 1991
AIA-PACK FT4
K913493 · CEC
Tosoh Corp.
Chemistry · 35d
Cleared Sep 06, 1991
ENZYME LINEARITY CONTROL
K912718 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 80d
Cleared Sep 06, 1991
DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL
K913650 · DIF
Duo Research, Inc.
Chemistry · 21d
Cleared Sep 04, 1991
KODAK EKTACHEM DTII SYSTEM
K912844 · JJE
Eastman Kodak Company
Chemistry · 70d
Cleared Aug 30, 1991
METROLAB MODEL 1500
K910806 · JJQ
Laboratorio Rodriguez Corswant S.R.L.
Chemistry · 185d
Cleared Aug 30, 1991
QMS - DIGOXIN
K913562 · LCS
Seradyn, Inc.
Chemistry · 21d
Cleared Aug 30, 1991
ROSYS MODELS 100 AND 200
K913664 · JQW
Packard Instrument Co., Inc.
Chemistry · 14d
Cleared Aug 28, 1991
PROACT CHOLESTEROL SYSTEMS
K912212 · CHH
Boehringer Mannheim Corp.
Chemistry · 100d
Cleared Aug 28, 1991
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET
K912439 · JJX
Hybritech, Inc.
Chemistry · 86d
Cleared Aug 26, 1991
NEW-VENT
K911809 · JKA
Concord/Portex
Chemistry · 125d
Cleared Aug 26, 1991
BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY
K913091 · KQN
American Laboratory Products Co., Ltd.
Chemistry · 45d
Cleared Aug 26, 1991
KODAK EKTACHEM DT SLIDES (ALB)
K913195 · CIX
Eastman Kodak Company
Chemistry · 39d
Cleared Aug 26, 1991
KODAK EKTACHEM DT SLIDES (LAC)
K913197 · KHP
Eastman Kodak Company
Chemistry · 39d