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
7129–7152 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 19, 1990
ABBOTT IMX PROLACTIN
K896162 · CFT
Abbott Laboratories
Chemistry · 87d
Cleared Jan 19, 1990
IGF-I BY EXTRACTION
K896808 · CFL
Nichols Institute Diagnostics
Chemistry · 46d
Cleared Jan 19, 1990
CLINISTAT TOTAL PROTEIN REAGENT TEST
K896916 · CEK
Heraeus Kulzer, Inc.
Chemistry · 39d
Cleared Jan 19, 1990
MILENIA (TM) TSH
K900014 · JLW
Diagnostic Products Corp.
Chemistry · 17d
Cleared Jan 18, 1990
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
K895648 · JIT
Ventrex Laboratories, Inc.
Chemistry · 120d
Cleared Jan 18, 1990
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
K895649 · JIT
Ventrex Laboratories, Inc.
Chemistry · 120d
Cleared Jan 18, 1990
CLINISTAT ALBUMIN REAGENT TEST
K896910 · CIX
Miles Diagnostics Div.
Chemistry · 38d
Cleared Jan 18, 1990
T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT
K896925 · KHQ
In Vitro Diagnostics, Inc.
Chemistry · 37d
Cleared Jan 11, 1990
TOTAL GALACTOSE
K894011 · KQP
Alpkem Corp.
Chemistry · 219d
Cleared Jan 11, 1990
SODIUM AND POTASSIUM STANDARD
K895717 · JIX
Data Medical Associates, Inc.
Chemistry · 108d
Cleared Jan 11, 1990
TRIGLYCERIDES TEST KIT
K895952 · CDT
Elite Technology, Inc.
Chemistry · 92d
Cleared Jan 11, 1990
PHOSPHORUS
K895999 · CEO
American Monitor Corp.
Chemistry · 90d
Cleared Jan 11, 1990
ASPARTATE AMINOTRANFERASE (AST)
K896000 · CIT
American Monitor Corp.
Chemistry · 90d
Cleared Jan 11, 1990
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · JIL
Boehringer Mannheim Corp.
Chemistry · 63d
Cleared Jan 11, 1990
REP(TM) SPE PLUS-30 PROCEDURES
K896572 · CFP
Helena Laboratories
Chemistry · 52d
Cleared Jan 11, 1990
FOLLICLE STIMULATING HORMONE-EIA-XT
K896864 · CGJ
In Vitro Diagnostics, Inc.
Chemistry · 36d
Cleared Jan 10, 1990
CHARISE CHARLES REAGENT STRIPS
K895282 · JIL
Lee Import Domestic Consulting
Chemistry · 139d
Cleared Jan 10, 1990
CLP COMPREHENSIVE LIPID CONTROL-LR
K896246 · JJY
Creative Laboratory Products, Inc.
Chemistry · 72d
Cleared Jan 10, 1990
CLP COMPREHENSIVE LIPID CONTROL-HR
K896247 · JJY
Creative Laboratory Products, Inc.
Chemistry · 72d
Cleared Jan 02, 1990
MATRIX(TM)-96
K896202 · JJJ
Canberra Industries, Inc.
Chemistry · 68d
Cleared Jan 02, 1990
DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY
K896522 · JJY
Casco Standards
Chemistry · 48d
Cleared Jan 02, 1990
LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
K896526 · JGS
Baxter Healthcare Corp
Chemistry · 50d
Cleared Jan 02, 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT
K896640 · CGJ
Medix Biotech, Inc.
Chemistry · 39d
Cleared Jan 02, 1990
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
K896692 · CEM
Baxter Healthcare Corp
Chemistry · 35d