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
11569–11592 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 24, 1981
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587 · JIS
Syva Co.
Chemistry · 20d
Cleared Mar 23, 1981
FUNGIZONE
K810784 · KIT
Dutchland Laboratories, Inc.
Chemistry
Cleared Mar 17, 1981
QUANTICHECK CONTROL PLASMA
K803081 · GGQ
Abbott Laboratories
Chemistry · 102d
Cleared Mar 17, 1981
FACT* HOME PREGNANCY TEST
K810581 · JHJ
Ortho Pharmaceutical Corp.
Chemistry · 14d
Cleared Mar 17, 1981
EMIT-TFG PRISMA THYROXINE ASSAY
K810586 · KLI
Syva Co.
Chemistry · 13d
Cleared Mar 17, 1981
CENTRIFI CHEM SYSTEM 400 ANALYZER
K810596 · JJE
Union Carbide Corp.
Chemistry · 11d
Cleared Mar 17, 1981
CORNING 925 CHLORIDE METER
K810615 · JFS
Corning Medical & Scientific
Chemistry · 8d
Cleared Mar 13, 1981
GERMCO TEST R GLUCOSE TEST KIT
K810567 · CGA
Fermco Biochemics, Inc.
Chemistry · 10d
Cleared Mar 11, 1981
GEMENI QUICK-MB SEPARATION KIT
K810534 · JHT
Gemini, Inc.
Chemistry · 13d
Cleared Mar 06, 1981
DAC-CEL DIAGNATAL
K810214 · JHI
Burroughs Wellcome Co.
Chemistry · 38d
Cleared Mar 06, 1981
NORMLCERA
K810268 · KIS
Medical Specialties Laboratories
Chemistry · 32d
Cleared Mar 06, 1981
PRE-VAP CAPS
K810394 · JJC
Sherman Boosalis
Chemistry · 16d
Cleared Mar 06, 1981
DIGITAL DISPENSING PUMP
K810509 · JQW
Dynatech Corp.
Chemistry · 10d
Cleared Mar 06, 1981
BECKMAN DU-8 SPECTROPHOTOMETER
K810511 · JJQ
Beckman Instruments, Inc.
Chemistry · 10d
Cleared Mar 04, 1981
SANDARE NITROPRUSSIDE TEST PROCEDURE
K810514 · JLC
Sandare Chemical Co., Inc.
Chemistry · 7d
Cleared Feb 26, 1981
ESKACHEM PAP REAGENT
K803234 · JFH
Smithkline Diagnostics, Inc.
Chemistry · 66d
Cleared Feb 26, 1981
UREA NITROGEN, KINETIC
K810087 · JGZ
Bio-Analytics Laboratories, Inc.
Chemistry · 44d
Cleared Feb 26, 1981
HTSH RIABEAD DIAGNOSTIC KIT
K810381 · CGJ
Abbott Laboratories
Chemistry · 13d
Cleared Feb 26, 1981
CHOLESTEROL REAGENT
K810405 · CHH
Gilford Diagnostics
Chemistry · 8d
Cleared Feb 26, 1981
GAMMA-GT REAGENT SYSTEM
K810434 · JQB
American Monitor Corp.
Chemistry · 7d
Cleared Feb 25, 1981
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K810302 · CEP
Bio-Rad
Chemistry · 20d
Cleared Feb 25, 1981
LIQUID SCINTILLATION SPECTROPHOTOMETER
K810345 · JJJ
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Feb 23, 1981
RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE
K810351 · CDP
Endocrine-Metabolic Center
Chemistry · 13d
Cleared Feb 23, 1981
ALT (UV) TEST
K810355 · CKA
Boehringer Mannheim Corp.
Chemistry · 13d