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
8617–8640 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 04, 1986
MED-PEN/MED-POINT
K853733 · CGA
Garid, Inc.
Chemistry · 454d
Cleared Dec 04, 1986
URINE DIAGNOSTIC REAGENT STRIPS
K862806 · JJB
Amatech International, Inc.
Chemistry · 134d
Cleared Dec 04, 1986
TRANSFERMETER
K863066 · JQF
J. D. Assoc.
Chemistry · 114d
Cleared Dec 04, 1986
TERUMO SENSIBEAD EIA FSH KIT
K863928 · CGJ
Terumo Medical Corp.
Chemistry · 57d
Cleared Dec 04, 1986
U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST
K863980 · CJE
U. S. Diagnostics, Inc.
Chemistry · 51d
Cleared Dec 04, 1986
U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST
K864081 · CHH
U. S. Diagnostics, Inc.
Chemistry · 45d
Cleared Dec 04, 1986
REFLOTRON(R) ALT (GPT)
K864082 · CKD
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared Dec 04, 1986
U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST
K864231 · CDT
U. S. Diagnostics, Inc.
Chemistry · 37d
Cleared Nov 28, 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Nov 28, 1986
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
K863963 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Nov 28, 1986
MICRO-READER
K864060 · JJQ
Hyperion, Inc.
Chemistry · 39d
Cleared Nov 28, 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K864230 · CKE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 31d
Cleared Nov 24, 1986
AMR RESEARCH TONOMETER
K862958 · LCH
Associated Medical Representatives
Chemistry · 111d
Cleared Nov 24, 1986
BILIRUBIN TOTAL
K863056 · CIG
J. D. Assoc.
Chemistry · 104d
Cleared Nov 24, 1986
GLUCOMETER-E
K863102 · CGA
J. D. Assoc.
Chemistry · 103d
Cleared Nov 24, 1986
FERROFAST
K863109 · JIY
J. D. Assoc.
Chemistry · 103d
Cleared Nov 24, 1986
MULTI-ANALYTE LIN-TROL
K863751 · JJY
Sigma Diagnostics, Inc.
Chemistry · 60d
Cleared Nov 24, 1986
CO-OXIMETER SOLUTIONS
K863825 · JKS
D.R.G. Scientific Industries
Chemistry · 55d
Cleared Nov 24, 1986
LIQUI-SERA COMBO LIGAND/TDM CONTROLS
K863849 · JJY
Biodiagnostic Intl
Chemistry · 55d
Cleared Nov 24, 1986
BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.
K863880 · CHL
D.R.G. Scientific Industries
Chemistry · 49d
Cleared Nov 24, 1986
UREA NITROGEN TEST
K863889 · CDL
U. S. Diagnostics, Inc.
Chemistry · 49d
Cleared Nov 24, 1986
IQ UREA NITROGEN
K863901 · JGZ
Bd Becton Dickinson Vacutainer...
Chemistry · 48d
Cleared Nov 24, 1986
TRIGLYCERIDES
K863923 · CDT
Tech-Co, Inc.
Chemistry · 47d
Cleared Nov 24, 1986
URIC ACID
K863924 · KNK
Tech-Co, Inc.
Chemistry · 47d