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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11497–11520 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 13, 1981
HCG RADIOIMMUNOASSAY
K811116 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 19d
Cleared May 13, 1981
PH/BLOOD GAS CONTROL (ABC)
K811143 · JJS
Instrumentation Laboratory CO
Chemistry · 16d
Cleared May 08, 1981
HANKS' BALANCED SALT SOLUTION W/O CA-MG
K810766 · KIP
Dutchland Laboratories, Inc.
Chemistry · 46d
Cleared May 08, 1981
RPMI 1640 MEDIUM
K810767 · KIT
Dutchland Laboratories, Inc.
Chemistry · 46d
Cleared May 08, 1981
GOAT SERUM-STERILE
K810775 · KIS
Dutchland Laboratories, Inc.
Chemistry · 46d
Cleared May 08, 1981
HANKS' BALANCED SALTS SOLUTION (MODIF.)
K810777 · KIP
Dutchland Laboratories, Inc.
Chemistry · 46d
Cleared May 08, 1981
LUTEINIZING HORMONE DIRECT RIA KIT 125/I
K811024 · CEP
Immunalysis Corporation
Chemistry · 23d
Cleared May 08, 1981
AUTOMATIC ELISA READER
K811111 · JJQ
Artek Systems Corp.
Chemistry · 15d
Cleared May 01, 1981
GELMAN ELECTROPHORESIS CONTROL
K811100 · JJY
Gelman Sciences, Inc.
Chemistry · 9d
Cleared Apr 29, 1981
SPOTAR
K810839 · ELW
Moyco Industries, Inc.
Chemistry · 33d
Cleared Apr 29, 1981
HELENA VMA-SMC COLUMN METHOD
K810992 · CDF
Helena Laboratories
Chemistry · 16d
Cleared Apr 29, 1981
GLUCOSCAN TEST STRIPS
K810993 · CGA
Lifescan, Inc.
Chemistry · 16d
Cleared Apr 29, 1981
LKB 4460 FLUORIMETER
K811019 · KHO
Lkb Instruments, Inc.
Chemistry · 14d
Cleared Apr 29, 1981
FILTER SAMPLER BLOOD SERUM FILTER
K811036 · JKA
Glasrock Plastics, Inc.
Chemistry · 13d
Cleared Apr 29, 1981
125 I-T4 RIA TEST KIT
K811070 · CDX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 9d
Cleared Apr 29, 1981
GLUCOSE REAGENT-ENZYMATIC-COLOR 500
K811074 · CGA
Reagents Applications, Inc.
Chemistry · 9d
Cleared Apr 23, 1981
AUTO REFRACTOMETER NR-1000
K802958 · HKO
Nippon Kogaku, Inc.
Chemistry · 154d
Cleared Apr 23, 1981
HEMOGLOBIN ELECTROPHORESIS CONTROL
K810919 · JBD
Isolab, Inc.
Chemistry · 17d
Cleared Apr 23, 1981
REAGENTS FOR QUANT. ENZYMATIC DETER.-TR.
K810951
Mid Tech, Inc.
Chemistry · 16d
Cleared Apr 23, 1981
IN-VITRO TBG RADIOIMMUNOASSAY TEST
K810967 · CEE
Clinical Assays, Inc.
Chemistry · 15d
Cleared Apr 23, 1981
WORTHINGTON CK (NAC) REAGENT SET
K810997 · JHS
Worthington Diagnostic Systems
Chemistry · 10d
Cleared Apr 17, 1981
GOT ISOENZYME ASSAY EIKEN KIT
K802447 · CIT
Syn-Kit, Inc.
Chemistry · 191d
Cleared Apr 17, 1981
DAC-CEL HCG
K810215 · JHI
Burroughs Wellcome Co.
Chemistry · 80d
Cleared Apr 17, 1981
GILUCOCHEK REFLECTANCE METER
K810665 · JJQ
Lifescan, Inc.
Chemistry · 37d