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
7465–7488 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 04, 1989
ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
K891469 · CKA
Trace Scientific , Ltd.
Chemistry · 20d
Cleared Mar 31, 1989
ACCULEVEL ONE-STEP THEOPHYLLINE TEST
K885253 · KLS
Syva Co.
Chemistry · 98d
Cleared Mar 31, 1989
ROCHE CHLORIDE ELECTRODE
K890528 · CGA
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Mar 31, 1989
REVISED MAGNESIUM TEST ITEM NUMBER: SR1019
K890798 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Mar 28, 1989
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE
K884184 · LCP
Sigma Diagnostics, Inc.
Chemistry · 175d
Cleared Mar 28, 1989
TECHNICON DAX(TM) SYSTEM
K885203 · JJG
Technicon Instruments Corp.
Chemistry · 99d
Cleared Mar 28, 1989
QMS(TM) - THEOPHYLLINE
K885263 · JQX
Seradyn, Inc.
Chemistry · 95d
Cleared Mar 28, 1989
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE
K885272 · DIH
Sigma Chemical Co.
Chemistry · 96d
Cleared Mar 28, 1989
VENTREX COATED TUBE HCG
K890549 · JHI
Ventrex Laboratories, Inc.
Chemistry · 53d
Cleared Mar 28, 1989
COTUBE(TM) TSH IRMA
K890802 · JLW
Bio-Rad
Chemistry · 40d
Cleared Mar 28, 1989
KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0
K890927 · JJE
Eastman Kodak Company
Chemistry · 32d
Cleared Mar 28, 1989
KODAK EKTACHEM 500 ANALYZER
K890928 · JJE
Eastman Kodak Company
Chemistry · 32d
Cleared Mar 28, 1989
KODAK EKTACHEM 750 SERIES ANALYZER
K890929 · JJE
Eastman Kodak Company
Chemistry · 32d
Cleared Mar 28, 1989
ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)
K890997 · KEA
Atlantic Wholesale, Inc.
Chemistry · 29d
Cleared Mar 28, 1989
MAGNESIUM REAGENT
K891355 · JGJ
Medical Analysis Systems, Inc.
Chemistry · 18d
Cleared Mar 24, 1989
GAMMA-GLUTAMYLTRANSFERASE
K890312 · JQB
American Monitor Corp.
Chemistry · 60d
Cleared Mar 24, 1989
ABBOTT OVULATION PREDICTOR TEST
K890510 · CEP
Abbott Laboratories
Chemistry · 51d
Cleared Mar 24, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT ALP
K890521 · CJE
Abbott Laboratories
Chemistry · 50d
Cleared Mar 24, 1989
KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT
K890573 · JIY
Kenlor Industries, Inc.
Chemistry · 46d
Cleared Mar 24, 1989
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
K890908 · KHO
Baxter Healthcare Corp
Chemistry · 29d
Cleared Mar 22, 1989
COBAS MFC
K885292 · JQP
Roche Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Mar 22, 1989
IQ/QCA PHOSPHORUS
K891218 · CEO
Bd Becton Dickinson Vacutainer...
Chemistry · 15d
Cleared Mar 21, 1989
BIOTROL URINE PROTEINS REAGENT
K890846 · JIR
Biotrol, USA, Inc.
Chemistry · 28d
Cleared Mar 20, 1989
AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)
K890708 · JJY
Amersham Corp.
Chemistry · 48d