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
9505–9528 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 19, 1985
GLUTAMYLTRANSFERASE ASSAY KIT
K850788 · JPZ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 21d
Cleared Mar 14, 1985
ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS
K850334 · CHJ
Roche Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Mar 14, 1985
SPECTRONIC 2000 SPECTROPHOTOMETER
K850767 · JJQ
Bausch & Lomb, Inc.
Chemistry · 17d
Cleared Mar 14, 1985
AMYLASE PRODUCTS
K850798 · JFJ
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Mar 13, 1985
PORTABLE DIAGNOSTIC LABORATORY
K844476 · LIB
Portable Medical Laboratories, Inc.
Chemistry · 114d
Cleared Mar 12, 1985
UROTRON RL9
K850348 · JJQ
Boehringer Mannheim Corp.
Chemistry · 43d
Cleared Mar 12, 1985
ROTOR SYSTEMS A/S-400 & LA/S-400
K850485 · JQC
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 33d
Cleared Mar 12, 1985
CORNING 780 FLUOROMETER/DENSITOMETER
K850617 · JQT
Corning Medical & Scientific
Chemistry · 25d
Cleared Mar 12, 1985
INNOFLUOR THEOPHYLLINE
K850629 · LGS
Innotron Diagnostics
Chemistry · 21d
Cleared Mar 12, 1985
SPECTRONIC 501 & 601 - CLINICAL SPECTROPHOTOMETER
K850709 · JJQ
Bausch & Lomb, Inc.
Chemistry · 18d
Cleared Mar 11, 1985
PERIDOCHROM TRIGLYCERIDES GPO
K850667 · CDT
Boehringer Mannheim Corp.
Chemistry · 19d
Cleared Mar 11, 1985
SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER
K850708 · JJQ
Bausch & Lomb, Inc.
Chemistry · 17d
Cleared Mar 05, 1985
LIQUI-HEME HEMOGLOBIN CALIBRATORS
K842668 · KRZ
Biodiagnostic Intl
Chemistry · 238d
Cleared Mar 05, 1985
PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU
K844135 · CHO
Immuno Nuclear Corp.
Chemistry · 133d
Cleared Mar 05, 1985
TSH-STAT
K844583 · JLW
Nuclear Medical Laboratories, Inc.
Chemistry · 102d
Cleared Mar 05, 1985
LEUCINE AMINOPEPTIDASE REAGENT
K844965 · JGG
Alladin Diagnostic, Inc.
Chemistry · 71d
Cleared Mar 05, 1985
PRECINORM H & PRECIPATH H
K850017 · JJY
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Mar 05, 1985
NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
K850079 · LCX
Bioclinical Systems, Inc.
Chemistry · 54d
Cleared Mar 05, 1985
ISOCONTROL SERUM CK-MB
K850213 · JJT
Sclavo, Inc.
Chemistry · 49d
Cleared Mar 05, 1985
BCS GLUCOSE COLORIMETRIC TEST
K850257 · CGA
Bioclinical Systems, Inc.
Chemistry · 42d
Cleared Mar 05, 1985
WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D
K850359 · LDM
Millipore Corp.
Chemistry · 34d
Cleared Mar 05, 1985
GLUCOSE - TRINDER- REAGENT
K850364 · CGA
Sigma Chemical Co.
Chemistry · 34d
Cleared Mar 05, 1985
OVU STICK SELF-TEST -MODIFICATION
K850480 · CEP
Monoclonal Antibodies, Inc.
Chemistry · 34d
Cleared Mar 05, 1985
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
K850639 · CIW
Bio-Analytics Laboratories, Inc.
Chemistry · 14d