FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
12001–12024 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 13, 1980
CALBIOCHEM-BEHRING RIA-COUNT
K792460 · CDD
Calbiochem-Behring Corp.
Chemistry · 72d
Cleared Feb 13, 1980
MICROMEDIC PUNCH & ELUTER
K800075 · JQW
Micromedic Systems
Chemistry · 30d
Cleared Feb 13, 1980
SYSTEM 203 CHEMISTRY ANALYZER
K800085 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 30d
Cleared Feb 13, 1980
LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS
K800106 · CEP
Radioimmunoassay, Inc.
Chemistry · 28d
Cleared Feb 13, 1980
FOLLICLE STIMULATING HORMONE
K800107 · CGJ
Radioimmunoassay, Inc.
Chemistry · 28d
Cleared Feb 13, 1980
CO2 CONTENT
K800111 · CIL
American Monitor Corp.
Chemistry · 28d
Cleared Feb 13, 1980
DURAZYME GPT/ALT
K800115 · CKA
American Monitor Corp.
Chemistry · 26d
Cleared Feb 13, 1980
DURAZYME GOT/AST
K800116 · CIT
American Monitor Corp.
Chemistry · 26d
Cleared Feb 13, 1980
LDH (L-P) REAGENT
K800120 · CFJ
Gilford Diagnostics
Chemistry · 26d
Cleared Feb 13, 1980
RSL (125 L) PROGESTERONE KIT
K800126 · JLS
Radioassay Systems Laboratories, Inc.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM CK
K800127 · CGS
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM BUN
K800128 · CDQ
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM CREATININE
K800129 · CEX
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
CENTRIFICHEM URIC ACID
K800130 · CDO
Union Carbide Corp.
Chemistry · 26d
Cleared Feb 13, 1980
ACCUSTROKE PIPET
K800141 · JQW
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Feb 13, 1980
VENTRE/SEP T3 UPTAKE RADIOASSAY
K800165 · KHQ
Ventrex Laboratories, Inc.
Chemistry · 19d
Cleared Feb 13, 1980
AMES RIALYZE - CHROMATOGRAPHY TUBES
K800169 · CDX
Miles Laboratories, Inc.
Chemistry · 19d
Cleared Feb 13, 1980
AMES RIALYZE - UPTAKE CHROM. TUBES
K800170 · KHQ
Miles Laboratories, Inc.
Chemistry · 19d
Cleared Feb 13, 1980
EMC-M-175, THYROXINE - 100 TUBES
K800187 · CDX
Endocrine-Metabolic Center
Chemistry · 15d
Cleared Feb 13, 1980
EMC-M-180, T3 UPTAKE - 100 TUBES
K800188 · KHQ
Endocrine-Metabolic Center
Chemistry · 15d
Cleared Feb 13, 1980
BOVINE ALBUMIN 22% & 30% SOLUTIONS
K800189 · KSG
Gotham Biologics, Inc.
Chemistry · 15d
Cleared Feb 13, 1980
STANBIO DIRECT URIC ACID TEST SET #0770
K800190 · CDH
Stanbio Laboratory
Chemistry · 15d
Cleared Feb 11, 1980
MICRO ELISA MINI READER
K800057 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 32d
Cleared Feb 11, 1980
PIPET CALIBRATION KIT
K800062 · JIS
Streck Laboratories, Inc.
Chemistry · 31d