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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12529–12552 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 27, 1978
ORTHO*T-3 UPTAKE KIT
K781482 · KHQ
Ortho Diagnostics, Inc.
Chemistry · 30d
Cleared Sep 27, 1978
ORTHO*T-4 RIA (PEG) KIT
K781483 · CDX
Ortho Diagnostics, Inc.
Chemistry · 30d
Cleared Sep 27, 1978
TECHNICON STAT/LYTE ISE ELECTROLYTE
K781503 · JJC
Technicon Instruments Corp.
Chemistry · 28d
Cleared Sep 27, 1978
COULTER ELECTROLYTE ANALYZER SYSTEM
K781528 · JJE
Coulter Electronics, Inc.
Chemistry · 22d
Cleared Sep 20, 1978
PRECISION GAS MIXER
K781417 · LCH
Medicor USA , Ltd.
Chemistry · 35d
Cleared Sep 20, 1978
BIOSCAN E12
K781421 · JJS
Clinifax Industries, Ltd.
Chemistry · 34d
Cleared Sep 20, 1978
LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA
K781454 · CHW
Union Carbide Corp.
Chemistry · 29d
Cleared Sep 14, 1978
COMPUTER INTERFACE IL 814
K781173 · JQP
Instrumentation Laboratory CO
Chemistry · 63d
Cleared Sep 14, 1978
STANDARDIZE TGCL & TGCH
K781376 · JTX
American Monitor Corp.
Chemistry · 36d
Cleared Sep 14, 1978
EBS 775 TONOMETER
K781386 · LCH
Equilibrated Bio Systems, Inc.
Chemistry · 34d
Cleared Sep 14, 1978
CREATININE REAGENT SET
K781396 · CGX
Nobel Scientific Industries, Inc.
Chemistry · 35d
Cleared Sep 01, 1978
SYSTEM 6000 AUTOMATED RIA ANALYZER
K780886 · LCI
Beckman Instruments, Inc.
Chemistry · 98d
Cleared Aug 31, 1978
GLOBULIN TEST, HUMAN THYROXINE BINDING
K781225 · CEE
Hyland Therapeutic Div., Travenol...
Chemistry · 44d
Cleared Aug 31, 1978
RABBIT ANTIBODY TO HUMAN T3
K781284 · CDP
Pcl-Ria, Inc.
Chemistry · 36d
Cleared Aug 31, 1978
THYRO-SHURE
K781296 · JLW
Nuclear Medical Laboratories, Inc.
Chemistry · 35d
Cleared Aug 31, 1978
UREA NITROGEN
K781305 · CDW
Analytical & Research Chemicals, Inc.
Chemistry · 34d
Cleared Aug 31, 1978
UREA NITROGEN TEST KIT
K781306 · CDL
Analytical & Research Chemicals, Inc.
Chemistry · 34d
Cleared Aug 31, 1978
GLUCOSE DETERM. KIT
K781307 · CGA
Analytical & Research Chemicals, Inc.
Chemistry · 34d
Cleared Aug 31, 1978
GLUCOLOUR
K781308 · CGE
Analytical & Research Chemicals, Inc.
Chemistry · 34d
Cleared Aug 31, 1978
GOT PROCEDURE
K781309
Analytical & Research Chemicals, Inc.
Chemistry · 34d
Cleared Aug 31, 1978
HUMAN CHORIONIC GONADO.-BETA RIA KIT
K781310 · JHI
Diagnostics Biochem Canada, Inc.
Chemistry · 31d
Cleared Aug 31, 1978
LDH PROCEDURE
K781323
Analytical & Research Chemicals, Inc.
Chemistry · 31d
Cleared Aug 31, 1978
ALP TEST
K781324 · CIO
Analytical & Research Chemicals, Inc.
Chemistry · 31d
Cleared Aug 31, 1978
GLUCOSE TEST
K781342 · CGA
Wako Intl., Inc.
Chemistry · 27d