OPTIONAL TOTAL CA-MODULE FOR IL 504/508— 510(k) K812872

Name: FDA 510(k) clearance K812872
Creator: U.S. Food and Drug Administration
Published: 1981-10-26

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K812872 for OPTIONAL TOTAL CA-MODULE FOR IL 504/508, Substantially Equivalent on 1981-10-26. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code CIS
Device class: Class 2
Regulation: 21 CFR 862.1100
Advisory panel: Clinical Chemistry
Date received: 1981-10-14
Decision date: 1981-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIS

view all

K032027 — CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)2003-09-05
K896238 — COBAS READY AST REAGENT1990-02-16
K854187 — IN-VITRO TEST DETERMINATION OF SGOT (AST)1985-11-25
K792410 — ELVI SGOT & SGPT TRANSAMINASE1979-12-06

More clearances from Instrumentation Laboratory CO

view all

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
K223402 — HemosIL von Willebrand Factor Antigen2022-12-09
K213464 — HemosIL Liquid Anti-Xa2022-10-04

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