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
10681–10704 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 09, 1983
IL 943 FLAME PHOTOMETER
K823480 · JJO
Instrumentation Laboratory CO
Chemistry · 47d
Cleared Jan 09, 1983
FLOW-PAC LDH REAGENT SET
K823721 · CFJ
Amresco, Inc.
Chemistry · 30d
Cleared Jan 09, 1983
API MDS*
K823785 · JQP
Analytical Products, Inc.
Chemistry · 24d
Cleared Jan 07, 1983
ESTROCEPT STABILIZED ESTROGEN RECEPTOR
K823186 · JJX
Brl
Chemistry · 73d
Cleared Jan 07, 1983
CK-ISOZYME U.V. REAGENT SET
K823550 · JHT
Gelman Sciences, Inc.
Chemistry · 38d
Cleared Jan 07, 1983
COBAS STANDARDS FOR CREATININE
K823572 · CGX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR CREATININE
K823573 · CGX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR ALBUMIN
K823574 · CIX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARDS FOR ALBUMIN
K823575 · CIX
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARD FOR TOTAL PROTEIN
K823576 · LER
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR CALCIUM
K823577 · CIC
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
K823578 · CIO
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR TOTAL PROTEIN
K823579 · CEK
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
COBAS REAGENT FOR INORGANIC PHOSPHORUS
K823580 · CEO
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Jan 07, 1983
NML 6000 CT
K823679 · JQP
Nuclear Medical Laboratories, Inc.
Chemistry · 31d
Cleared Jan 07, 1983
BETA FFIRM TEST
K823682 · JHJ
Organon, Inc.
Chemistry · 31d
Cleared Jan 07, 1983
BIO INTERFERENCE BLANKING MATERIAL
K823687 · JJX
American Monitor Corp.
Chemistry · 31d
Cleared Jan 07, 1983
PHOSPHORUS REAGENT SET
K823691 · CEO
Omega Medical Electronics
Chemistry · 30d
Cleared Jan 07, 1983
TRIGLYCERIDE REAGENT (UV)
K823709 · CDT
Gilford Diagnostics
Chemistry · 29d
Cleared Jan 07, 1983
SPECTROPHOTOMETER
K823720 · JJQ
Macomb Chemical Co.
Chemistry · 28d
Cleared Jan 07, 1983
ADVANCE EMIT-AED PRIMEDONE ASSAY
K823741 · LFT
Syva Co.
Chemistry · 25d
Cleared Jan 07, 1983
ADVANCE EMIT-AED ETHOSUXIMIDE
K823745 · DLF
Syva Co.
Chemistry · 25d
Cleared Jan 05, 1983
ORTHO BI-LEVEL ASSAYED LIPID PROFILE
K823490 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 05, 1983
COAT-A-COUNT MORPHINE KIT & COMPONENTS
K823680 · DDE
Diagnostic Products Corp.
Chemistry · 29d