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
7177–7200 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 05, 1989
SYNCHRON CX SYSTEMS (LAP) REAGENT KIT
K895850 · JGG
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Dec 01, 1989
MILENIA(TM) HCG (MKCG1,5)
K895809 · JHI
Diagnostic Products Corp.
Chemistry · 90d
Cleared Dec 01, 1989
ISOSCREEN-CK CONFIRMATORY KIT
K895870 · JHY
Roche Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Dec 01, 1989
IMMUNOCARD HCG II-S TEST KIT
K895912 · JHI
Disease Detection International, Inc.
Chemistry · 52d
Cleared Nov 30, 1989
MODIFIED MODEL 535(TM) LUMINOMETER
K896117 · JJQ
Los Alamos Diagnostics
Chemistry · 41d
Cleared Nov 29, 1989
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT
K895851 · LBS
Beckman Instruments, Inc.
Chemistry · 57d
Cleared Nov 22, 1989
STATSPIN STATSAMPLER
K896206 · JKA
Statspin Technologies
Chemistry · 27d
Cleared Nov 21, 1989
EPO-TRAC BY RADIOIMMUNOASSAY (RIA)
K893393 · GGT
Incstar Corp.
Chemistry · 204d
Cleared Nov 21, 1989
DSL I-PTH (DSL #8000)
K896294 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 21d
Cleared Nov 17, 1989
PROTOFLUOR Z
K893038 · JKJ
Helena Laboratories
Chemistry · 207d
Cleared Nov 17, 1989
VISION PHENYTOIN
K896074 · DIP
Abbott Laboratories
Chemistry · 29d
Cleared Nov 17, 1989
FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT
K896222 · CEC
Nichols Institute Diagnostics
Chemistry · 18d
Cleared Nov 14, 1989
TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD
K895664 · CEM
Technicon Instruments Corp.
Chemistry · 55d
Cleared Nov 14, 1989
QUANTIMETRIX BILIRUBIN CALIBRATORS
K895778 · JIS
Quantimetrix Medical Industries
Chemistry · 48d
Cleared Nov 14, 1989
TOTAL BILIRUBIN L.F.
K895822 · CIG
Sclavo, Inc.
Chemistry · 46d
Cleared Nov 14, 1989
GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600
K896028 · CFR
American Research Products Co.
Chemistry · 29d
Cleared Nov 13, 1989
TDX(R) LITES(TM) LITHIUM
K894328 · JIH
Abbott Laboratories
Chemistry · 122d
Cleared Nov 13, 1989
CARDS O.S. (TM) HCG-URINE
K895390 · JHI
Pacific Biotech, Inc.
Chemistry · 75d
Cleared Nov 13, 1989
MODIFIED HOMECLINIC PREGNANCY TEST
K895560 · LCX
Vanguard Biomedical Corp.
Chemistry · 68d
Cleared Nov 13, 1989
HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)
K895585 · JIS
Hichem Diagnostics
Chemistry · 59d
Cleared Nov 13, 1989
ALANINE AMINOTRANSFERASE (ALT)
K896001 · CKA
American Monitor Corp.
Chemistry · 31d
Cleared Nov 08, 1989
QUANTAI UG REAGENT STRIP
K893661 · CGA
Quantai Biotronics, Inc.
Chemistry · 177d
Cleared Nov 08, 1989
CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS
K894715 · CGS
Catachem, Inc.
Chemistry · 106d
Cleared Nov 08, 1989
FIAGEN T3 UPTAKE CATALOGUE #101-402
K895186 · KHQ
Cyberfluor, Inc.
Chemistry · 89d