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
7321–7344 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 21, 1989
SINGLE AND DUAL BAND DIPSTICK HCG TEST
K893873 · DHA
Ampcor, Inc.
Chemistry · 87d
Cleared Aug 21, 1989
ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER
K894069 · JQW
Abbott Laboratories
Chemistry · 74d
Cleared Aug 21, 1989
DENLEY ANTHOS 2001 READER
K894270 · JJQ
Denley Instruments, Inc.
Chemistry · 60d
Cleared Aug 21, 1989
DENLEY WELLDILL 3
K894272 · JQW
Denley Instruments, Inc.
Chemistry · 60d
Cleared Aug 17, 1989
AMYLASE TEST (AML) ITEM NUMBER: 65404
K893751 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 15, 1989
TARGET(TM) CK-MB
K890295 · JHY
V-Tech, Inc.
Chemistry · 208d
Cleared Aug 15, 1989
ABBOTT SPECTRUM AMYLASE REAGENT
K891241 · JFJ
Abbott Laboratories
Chemistry · 161d
Cleared Aug 15, 1989
CHLORIDE STANDARDS ITEM #SR1041
K891999 · JIT
Em Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Aug 15, 1989
CLINISTAT TOTAL BILIRUBIN REAGENT TEST
K892801 · CIG
Heraeus Kulzer, Inc.
Chemistry · 120d
Cleared Aug 15, 1989
INNOFLUOR CARBAMAZEPINE CALIBRATOR SET
K893506 · DLJ
Innotron of Oregon, Inc.
Chemistry · 102d
Cleared Aug 15, 1989
BECKMAN CHOLINESTERASE REAGENT KIT
K893583 · DIH
Beckman
Chemistry · 98d
Cleared Aug 15, 1989
MODIFIED PK300 AUTOMATIC EIA ANALYZER
K893768 · JJF
Olympus Corp.
Chemistry · 88d
Cleared Aug 15, 1989
ABSOLUTE(TM)-HCG URINE PREGNANCY TEST
K893953 · DHA
Totem Diagnostics, Inc.
Chemistry · 75d
Cleared Aug 15, 1989
ROBOTIC SAMPLE PROCESSOR
K894126 · JQW
Tecan U.S., Ltd.
Chemistry · 64d
Cleared Aug 15, 1989
DENLEY WELLWASH 2 AND 4
K894271 · JQW
Denley Instruments, Inc.
Chemistry · 54d
Cleared Aug 15, 1989
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
K894279 · CEP
Bd Becton Dickinson Vacutainer...
Chemistry · 53d
Cleared Aug 11, 1989
INNOFLUOR CARBAMAZEPINE REAGENT SET
K893507 · KLT
Innotron of Oregon, Inc.
Chemistry · 98d
Cleared Aug 11, 1989
T3 CLASP-BEAD EIA KIT
K893620 · CDP
Biotecx Laboratories, Inc.
Chemistry · 92d
Cleared Aug 11, 1989
OLYMPUS ISE MODULE FOR AU5000
K893628 · CGZ
Olympus Corp.
Chemistry · 92d
Cleared Aug 11, 1989
DIRECT BILIRUBIN REAGENT
K893730 · CIG
Medical Analysis Systems, Inc.
Chemistry · 86d
Cleared Aug 11, 1989
QUIDEL REFLECTANCE ANALYZER
K893738 · JJQ
Quidel Corp.
Chemistry · 86d
Cleared Aug 11, 1989
ROCHE REAGENT FOR TRIGLYCERIDES
K893973 · CDT
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Aug 11, 1989
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
K894078 · JJY
Bio-Rad
Chemistry · 56d
Cleared Aug 10, 1989
BIOTROL CALCIUM MONOREACTIF
K891061 · CJY
Biotrol, USA, Inc.
Chemistry · 162d