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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
12505–12528 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 03, 1978
EPPENDORF PCP 6121
K781544 · JJQ
Marilyn L. Amick
Chemistry · 25d
Cleared Oct 02, 1978
BIO-PRO UNIT
K781303 · FKR
Bd Becton Dickinson Vacutainer...
Chemistry · 67d
Cleared Sep 27, 1978
IMMO PHASE, THYROID HORMONE
K781409 · JLW
Corning Medical & Scientific
Chemistry · 44d
Cleared Sep 27, 1978
RIALYZE VITAMIN B-12 TEST
K781410 · CDD
Ames Div., Miles Laboratories, Inc.
Chemistry · 44d
Cleared Sep 27, 1978
MITROPHENYL, ALKALINE PHOSPHATES
K781472 · CJE
Beckman Instruments, Inc.
Chemistry · 30d
Cleared Sep 27, 1978
ORTHO*T-3 RIA (PEG) KIT
K781481 · CDP
Ortho Diagnostics, Inc.
Chemistry · 30d
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