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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
5257–5280 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 13, 1995
COAT-A-COUNT NEONATAL TSH IRMA
K943195 · JLW
Diagnostic Products Corp.
Chemistry · 251d
Cleared Mar 13, 1995
CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
K950186 · JHW
Miles, Inc.
Chemistry · 55d
Cleared Mar 10, 1995
DELFIA NEONATAL THYROXINE KIT
K943416 · CDX
Wallac OY
Chemistry · 238d
Cleared Mar 10, 1995
ABL5 BLOOD GAS SYSTEM
K943882 · CHL
Radiometer America, Inc.
Chemistry · 213d
Cleared Mar 10, 1995
IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)
K944933 · JMF
Diagnostic Products Corp.
Chemistry · 155d
Cleared Mar 09, 1995
STAT PROFILE PLUS 9 ANALYZER
K936066 · KHP
Nova Biomedical Corp.
Chemistry · 443d
Cleared Mar 09, 1995
STAT PROFILE PLUS 10 ANALYZER
K936203 · CHL
Nova Biomedical Corp.
Chemistry · 443d
Cleared Mar 03, 1995
MICROPLATE PROCESSOR 3000
K945135 · JJE
Organon Teknika Corp.
Chemistry · 134d
Cleared Mar 03, 1995
CK QVET
K950177 · CGS
Prisma Systems
Chemistry · 45d
Cleared Mar 01, 1995
BUN REAGENT
K942984 · CDQ
American Research Products Co.
Chemistry · 254d
Cleared Mar 01, 1995
DMA ALBUMIN PROCEDURE
K946355 · CIX
Data Medical Associates, Inc.
Chemistry · 61d
Cleared Mar 01, 1995
BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST
K950307 · DHA
Princeton BioMeditech Corp.
Chemistry · 35d
Cleared Feb 24, 1995
I.D. AND SEAKEM GTG AGAROSES
K940037 · JZR
Fmc Corp.
Chemistry · 416d
Cleared Feb 24, 1995
NEOSCREEN ELISA TSH
K942658 · JLW
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 263d
Cleared Feb 23, 1995
COAT-A-COUNT(R) ESTRADIOL-6
K943193 · CHP
Diagnostic Products Corp.
Chemistry · 233d
Cleared Feb 23, 1995
HICHEM LDH/L REAGENT KIT
K946022 · CFJ
Hichem Diagnostics
Chemistry · 73d
Cleared Feb 22, 1995
LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN
K944325 · JHW
Princeton BioMeditech Corp.
Chemistry · 173d
Cleared Feb 22, 1995
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
K944697 · CEC
Organon Teknika Corp.
Chemistry · 152d
Cleared Feb 22, 1995
340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER
K945408 · CHJ
Catachem, Inc.
Chemistry · 111d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL
K946063 · CHH
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL CASSETTE
K946064 · CHH
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
K946065 · CHH
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL
K946066 · CHH
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL
K946067 · CHH
Cholestech Corp.
Chemistry · 99d