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
11257–11280 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 10, 1981
ULTRACHEM CREA ITEM #64972
K813043 · CGX
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM ALB, ITEM #64970
K813044 · CIX
Harleco
Chemistry · 13d
Cleared Nov 06, 1981
ALT-QUANTICHROM
K812926 · CKA
Abbott Laboratories
Chemistry · 18d
Cleared Nov 06, 1981
LIQUILYME BUN REAGENT
K812945 · LFP
Amresco, Inc.
Chemistry · 17d
Cleared Nov 06, 1981
ACCURATE BETA
K812967 · JHJ
Organon, Inc.
Chemistry · 15d
Cleared Nov 06, 1981
URIC ACID SYSTEM PACK TEST
K812978 · KNK
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Nov 05, 1981
URICAR
K812700 · KNK
Hi Chem, Inc.
Chemistry · 43d
Cleared Nov 05, 1981
GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT
K812727 · CGC
Immuno Nuclear Corp.
Chemistry · 38d
Cleared Nov 02, 1981
CLEANING SOLUTION FOR RADIOMETER OSM2
K812623 · CHL
Fisher Scientific Co., LLC
Chemistry · 48d
Cleared Nov 02, 1981
GILCHEM ALP REAGENT
K812912 · CJE
Gilford Diagnostics
Chemistry · 14d
Cleared Nov 02, 1981
ANSWER (R)
K812924 · JHJ
Armkel, LLC
Chemistry · 14d
Cleared Oct 26, 1981
OPTIONAL TOTAL CA-MODULE FOR IL 504/508
K812872 · CIS
Instrumentation Laboratory CO
Chemistry · 12d
Cleared Oct 26, 1981
PENASE
K812877 · JTO
Analytab Products, Inc.
Chemistry · 12d
Cleared Oct 23, 1981
CHOLESTEROL CALIBRATORS
K812861 · JIS
Gilford Diagnostics
Chemistry · 10d
Cleared Oct 20, 1981
IL 501, NA/K ANALYZER
K812762 · JGS
Instrumentation Laboratory CO
Chemistry · 19d
Cleared Oct 20, 1981
BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD
K812784 · CIG
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Oct 20, 1981
LIPASE
K812794 · CET
Pointe Scientific, Inc.,
Chemistry · 14d
Cleared Oct 19, 1981
BECKMAN ICS CALIBRATOR
K812649 · JIX
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Oct 19, 1981
BECKMAN ICS NORMAL CONTROL SERA
K812650 · JJY
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Oct 19, 1981
BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN
K812754 · CIG
Beckman Instruments, Inc.
Chemistry · 19d
Cleared Oct 19, 1981
NML CK-MB RIA
K812759 · JHX
Nuclear Medical Laboratories, Inc.
Chemistry · 18d
Cleared Oct 19, 1981
DIRECT IRON REAGENT SET
K812777 · JIY
The Dow Chemical Co.
Chemistry · 14d
Cleared Oct 13, 1981
TANDEM QUALITATIVE HCG KIT
K812461 · JHI
Hybritech, Inc.
Chemistry · 43d
Cleared Oct 09, 1981
TOTAL CALCIUM REAGENT SET
K812835 · CIC
Anco Medical Reagents & Assoc.
Chemistry