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
10825–10848 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 08, 1982
ACUSCREEN
K822782 · GGW
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 30, 1982
FERMCOTEST CO2 REAGNET
K822117 · JFL
Fermco Biochemics, Inc.
Chemistry · 73d
Cleared Sep 30, 1982
FERMCOTEST CREATININE TEST REAGENT
K822118 · CGX
Fermco Biochemics, Inc.
Chemistry · 73d
Cleared Sep 30, 1982
ACA URINARY PROTEIN ANALYTICAL TEST PACK
K822231 · JGQ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 65d
Cleared Sep 30, 1982
DSL 1400
K822314 · CGI
Diagnostic Systems Laboratories, Inc.
Chemistry · 58d
Cleared Sep 30, 1982
CIDEX*DIALYZER DISINFECTING SOLUTION
K822535 · FKQ
Surgikos, Inc.
Chemistry · 37d
Cleared Sep 30, 1982
LEECO T3% DIAGNOSTIC KIT
K822575 · KHQ
Leeco Diagnostics, Inc.
Chemistry · 36d
Cleared Sep 30, 1982
T3 UPTAKE KITS
K822612 · KHQ
Pcl-Ria, Inc.
Chemistry · 31d
Cleared Sep 30, 1982
QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM
K822646 · JJT
Beckman Instruments, Inc.
Chemistry · 28d
Cleared Sep 30, 1982
GLUCOSCAN TEST STRIPS
K822697 · CGA
Lifescan, Inc.
Chemistry · 23d
Cleared Sep 30, 1982
GLUCOSCAN CONTROLS
K822698 · JJX
Lifescan, Inc.
Chemistry · 23d
Cleared Sep 28, 1982
COVALENT COAT RIA KIT
K822509 · CFP
Immuchem Corp.
Chemistry · 39d
Cleared Sep 28, 1982
MODEL UCG ASSAY
K822520 · JHI
Monoclonal Antibodies, Inc.
Chemistry · 36d
Cleared Sep 28, 1982
ACID FAST QUALITY CONTROL SLIDES
K822604 · LJG
Medastat Scientific Corp.
Chemistry · 32d
Cleared Sep 28, 1982
EMIT-AMD AMIKACIN ASSAY
K822657 · KLQ
Dade Behring, Inc.
Chemistry · 25d
Cleared Sep 21, 1982
CELLULOSE ACETATE MEMBRANE STRIPS
K822285 · JJN
Sartorius Filters, Inc.
Chemistry · 53d
Cleared Sep 21, 1982
OPTIMIZED UV-GOT REAGENT SET
K822493 · CIT
Biorent Diagnostic, Inc.
Chemistry · 34d
Cleared Sep 21, 1982
OPTIMIZED UV-GPT REAGENT SET
K822494 · CKA
Biorent Diagnostic, Inc.
Chemistry · 34d
Cleared Sep 21, 1982
SERA CHEM SMAC CALIBRATORS
K822496 · JIT
Fisher Scientific Co., LLC
Chemistry · 34d
Cleared Sep 17, 1982
CALCIUM STANDARD, ITEM #65075
K822473 · JIS
Emd Chemicals, Inc.
Chemistry · 31d
Cleared Sep 17, 1982
CREATININE STANDARD #65072
K822477 · JIS
Emd Chemicals, Inc.
Chemistry · 31d
Cleared Sep 17, 1982
OPTIMIZED UV-LDH REAGENT SET
K822492 · CFJ
Biorent Diagnostic, Inc.
Chemistry · 30d
Cleared Sep 14, 1982
ULTRACHEM ENZYMATIC CHOL. OXIDASE
K822418 · CHH
Emd Chemicals, Inc.
Chemistry · 34d
Cleared Sep 14, 1982
HCT CENTRIFUGE
K822445 · GKG
Boehringer Mannheim Corp.
Chemistry · 29d