Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

324 results for "Instrumentation Laboratory CO"
1–24 of 324
Search insights Median review: 63d Cleared: 100% Top manufacturer: Instrumentation Laboratory CO Lead specialty: Hematology
Cleared Dec 13, 2023
HemosIL Chromogenic Factor IX
K230852 · GGP
Instrumentation Laboratory Company
Hematology · 260d
Cleared Sep 29, 2023
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2...
K221359 · JPA
Instrumentation Laboratory CO
Hematology · 506d
Cleared Aug 10, 2023
GEM Premier 7000 with IQM3
K223608 · CHL
Instrumentation Laboratory Company
Chemistry · 251d
Cleared Jun 23, 2023
HemosIL Liquid Anti-Xa
K223187 · QLU
Instrumentation Laboratory CO
Hematology · 254d
Cleared Jun 21, 2023
ACL TOP Family 70 Series
K231031 · GKP
Instrumentation Laboratory Company
Hematology · 71d
Cleared Jan 27, 2023
GEM Premier ChemSTAT
K223090 · CGA
Instrumentation Laboratory CO
Chemistry · 119d
Cleared Dec 09, 2022
HemosIL von Willebrand Factor Antigen
K223402 · GGP
Instrumentation Laboratory CO
Hematology · 30d
Cleared Oct 04, 2022
HemosIL Liquid Anti-Xa
K213464 · KFF
Instrumentation Laboratory CO
Hematology · 341d
Cleared Aug 16, 2022
HemosIL ReadiPlasTin
K213426 · GJS
Instrumentation Laboratory CO
Hematology · 299d
Cleared Aug 20, 2021
GEM Premier 5000
K203790 · CHL
Instrumentation Laboratory CO
Chemistry · 235d
Not Cleared Sep 17, 2020
HemosIL Liquid Anti-Xa
DEN190032 · QLU
Instrumentation Laboratory CO
Hematology · 450d
Cleared Aug 19, 2020
HemosIL von Willebrand Factor Antigen
K200033 · GGP
Instrumentation Laboratory CO
Hematology · 225d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183555 · JFY
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183549 · JGS
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Feb 16, 2019
GEM Premier ChemSTAT
K183546 · CGA
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Mar 22, 2018
HemosIL Factor XII Deficient Plasma
K180486 · GJT
Instrumentation Laboratory CO
Hematology · 27d
Cleared Dec 29, 2017
GEM Premier 5000
K173403 · CHL
Instrumentation Laboratory CO
Chemistry · 59d
Cleared Nov 22, 2017
HemosIL D-Dimer HS 500
K172903 · DAP
Instrumentation Laboratory CO
Hematology · 61d
Cleared Sep 08, 2017
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
K170854 · LCO
Instrumentation Laboratory CO
Hematology · 170d
Cleared Mar 03, 2017
ACL AcuStar
K170314 · JPA
Instrumentation Laboratory CO
Hematology · 30d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin,...
K160415 · GKF
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
K160412 · CHL
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160402 · CGA
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized...
K160225 · JGS
Instrumentation Laboratory CO
Chemistry · 320d