Cleared Traditional

TBG DIAGNOSTIC KIT

K811725 · Immuno Assay Corp. · Chemistry
Jul 1981
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K811725 is an FDA 510(k) clearance for the TBG DIAGNOSTIC KIT, a Electrophoretic, Protein Fractionation (Class I — General Controls, product code CEF), submitted by Immuno Assay Corp. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981, 22 days after receiving the submission on June 18, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1630.

Submission Details

510(k) Number K811725 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1981
Decision Date July 10, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEF — Electrophoretic, Protein Fractionation
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1630

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