Cleared Traditional

OPTIONAL TOTAL CA-MODULE FOR IL 504/508

K812872 · Instrumentation Laboratory CO · Chemistry
Oct 1981
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K812872 is an FDA 510(k) clearance for the OPTIONAL TOTAL CA-MODULE FOR IL 504/508, a Hydrazone Colorimetry, Ast/sgot (Class II — Special Controls, product code CIS), submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on October 26, 1981, 12 days after receiving the submission on October 14, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K812872 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1981
Decision Date October 26, 1981
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIS — Hydrazone Colorimetry, Ast/sgot
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1100