COATEST SP FVIII— 510(k) K042576

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K042576 for COATEST SP FVIII, Substantially Equivalent on 2004-12-02. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2004-09-22
Decision date: 2004-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGP

K251440 — CRYOcheck Chromogenic Factor VIII2025-08-25
K230852 — HemosIL Chromogenic Factor IX2023-12-13
K220728 — vWF Ag2023-06-02
K214002 — CRYOcheck Chromogenic Factor IX2022-12-23
K223402 — HemosIL von Willebrand Factor Antigen2022-12-09

More clearances from Instrumentation Laboratory CO

K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM2023-09-29
K223187 — HemosIL Liquid Anti-Xa2023-06-23
K223090 — GEM Premier ChemSTAT2023-01-27
K213464 — HemosIL Liquid Anti-Xa2022-10-04
K213426 — HemosIL ReadiPlasTin2022-08-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.