Cleared Traditional

ENZYMUN TEST(R) TBK

K896991 · Boehringer Mannheim Corp. · Chemistry
Mar 1990
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K896991 is an FDA 510(k) clearance for the ENZYMUN TEST(R) TBK, a Radioimmunoassay, Thyroxine-binding Globulin (Class II — Special Controls, product code CEE), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on March 1, 1990, 78 days after receiving the submission on December 13, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1685.

Submission Details

510(k) Number K896991 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1989
Decision Date March 01, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEE — Radioimmunoassay, Thyroxine-binding Globulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1685

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