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
11305–11328 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 24, 1981
ULTRA ZYME PLUS LDH #64950, 65038 & 39
K812590 · CFJ
Harleco
Chemistry · 13d
Cleared Sep 24, 1981
ULTRA ZYME PLUS GPT, #64956, 65035 & 36
K812591 · CKA
Harleco
Chemistry · 13d
Cleared Sep 24, 1981
ULTRA ZYME PLUS GOT #64953, 65033 & 34
K812592 · CIT
Harleco
Chemistry · 13d
Cleared Sep 23, 1981
TITERTEK MICROPLATE INCUBATOR
K812340 · JTQ
Flow Laboratories, Inc.
Chemistry · 36d
Cleared Sep 23, 1981
CAMPY THIOGLYCOLLATE (TUBE)
K812451 · JSD
Granite Diagnostics, Inc.
Chemistry · 26d
Cleared Sep 23, 1981
ULTRACHEM URIC ACID ALDH, ITEM #65047
K812500 · CDO
Harleco
Chemistry · 23d
Cleared Sep 23, 1981
AMES TDA THEOPHYLLINE TEST
K812518 · LER
Miles Laboratories, Inc.
Chemistry · 21d
Cleared Sep 23, 1981
PROTEIN-BASED BLOOD GAS CONTROL
K812541 · JJS
American Dade
Chemistry · 19d
Cleared Sep 23, 1981
COROMETRICS MEDICAL SYST. 220 PH ANALY.
K812552 · CHL
Transidyne General Corp.
Chemistry · 19d
Cleared Sep 23, 1981
AQUEOUS BLOOD GAS CONTROLS
K812553 · JJS
Fisher Scientific Co., LLC
Chemistry · 15d
Cleared Sep 16, 1981
CRYOSAN NORMAL SALINE
K812309 · GIF
Cryosan, Inc.
Chemistry · 30d
Cleared Sep 16, 1981
PALL ULTIPOR VACUUM LINE BACTERIA FITLER
K812505 · JQC
Pall Biomedical Products Co.
Chemistry · 15d
Cleared Sep 14, 1981
KALLESTAD 125I ANTISERUM TO HUMAN IGE
K812414 · DHB
Kallestad Laboratories, Inc.
Chemistry · 24d
Cleared Sep 14, 1981
SPIN-CHEM TRIGLYCERIDES REAGENT
K812471 · CDT
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared Sep 14, 1981
SPIN-CHEM LD-L REAGENT
K812472 · CFJ
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared Sep 09, 1981
PLASMA FLEX
K811523 · KSR
Terumo America, Inc.
Chemistry · 103d
Cleared Sep 09, 1981
BLOOD UREA NITROGEN(BUN-UV)
K812417 · CDQ
Reagents Applications, Inc.
Chemistry · 16d
Cleared Sep 09, 1981
URIC ACID REAGENT SET
K812430 · KNK
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Sep 09, 1981
AMYLASE REAGENT KIT
K812447 · KHM
Bioscientific
Chemistry · 12d
Cleared Sep 09, 1981
ALKALINE PHOSPHATASE
K812452 · CJE
Pointe Scientific, Inc.,
Chemistry · 12d
Cleared Sep 08, 1981
VISIO-FIL
K812169 · EBF
Espe GmbH (Us)
Chemistry · 40d
Cleared Sep 01, 1981
REAGENT STRIPS FOR URINALYSIS
K811342 · JRE
Miles Laboratories, Inc.
Chemistry · 112d
Cleared Sep 01, 1981
TANDEM PAP KIT - (PARTS I & II)
K811959 · JFH
Hybritech, Inc.
Chemistry · 54d
Cleared Sep 01, 1981
GELMAN IG-FIX KIT
K812253 · CZP
Gelman Sciences, Inc.
Chemistry · 21d