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
9217–9240 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 19, 1985
CHEMPRO 1000
K854260 · CGA
Sen Tech Medical Corp.
Chemistry · 27d
Cleared Nov 19, 1985
MR 700 MICROPLATE READER 012-700-1000
K854303 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 25d
Cleared Nov 12, 1985
DOUBLE ANTIBODY C-PEPTIDE RIA KIT
K854066 · JKD
Diagnostic Products Corp.
Chemistry · 39d
Cleared Nov 12, 1985
KODAKEKTACHEM DTR MODULE
K854138 · JJE
Eastman Kodak Company
Chemistry · 33d
Cleared Nov 12, 1985
IRON
K854298 · CEM
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Nov 12, 1985
DART IRON & IRON BINDING CAPACITY REAGENT
K854305 · CFM
Coulter Electronics, Inc.
Chemistry · 18d
Cleared Nov 05, 1985
DEMAND ETHYL ALCOHOL
K854130 · DIC
Cooper Biomedical, Inc.
Chemistry · 27d
Cleared Nov 05, 1985
TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN
K854152 · CDT
Technicon Instruments Corp.
Chemistry · 25d
Cleared Nov 05, 1985
TDX COCAINE METABOLITE
K854163 · DIO
Abbott Laboratories
Chemistry · 21d
Cleared Nov 05, 1985
TDX PHENCYCLIDINE
K854167 · LCM
Abbott Laboratories
Chemistry · 21d
Cleared Oct 31, 1985
ILEX PROMPT CLINICAL CHEMISTRY ANALYER
K853068 · CEM
Ilex Corp.
Chemistry · 101d
Cleared Oct 28, 1985
SIGMA 610 FOR PROTEIN IN URINE & CSF
K853681 · CEK
Sigma Diagnostics, Inc.
Chemistry · 54d
Cleared Oct 28, 1985
ASTRA SYSTEMS CHOLESTEROL REAGENT
K853854 · CHH
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Oct 28, 1985
TDX AMPHETAMINE METHAMPHETAMINE
K853879 · DKZ
Abbott Laboratories
Chemistry · 40d
Cleared Oct 28, 1985
HITACHI 704
K854025 · JJE
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Oct 25, 1985
NML TSH IRMA
K854087 · JLW
Organon Teknika Corp.
Chemistry · 18d
Cleared Oct 25, 1985
DMA CALIBRATORS
K854092 · JIX
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Oct 25, 1985
ACCURACY
K854119 · JJY
Columbia Diagnostics, Inc.
Chemistry · 16d
Cleared Oct 22, 1985
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
K852392 · CGS
Helena Laboratories
Chemistry · 139d
Cleared Oct 22, 1985
BETA-TSH-IRMA
K853977 · JLW
Leeco Diagnostics, Inc.
Chemistry · 26d
Cleared Oct 18, 1985
DR. BRUNO LNAGE MINI PHOTOMETER
K851575
Texas Medical Products, Inc.
Chemistry · 184d
Cleared Oct 17, 1985
PHADEBACT CSF TEST
K844999 · GTJ
Pharmacia, Inc.
Chemistry · 295d
Cleared Oct 16, 1985
LH/FSH RADIOIMMUNOASSAY KIT
K853837 · CEP
Bioclinical Group
Chemistry · 30d
Cleared Oct 16, 1985
DEMAND ACID PHOSPHATASE REAGENT
K853949 · CKB
Cooper Biomedical, Inc.
Chemistry · 22d