Cleared Traditional

SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB

K920416 · Behring Diagnostics, Inc. · Microbiology
Apr 1992
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K920416 is an FDA 510(k) clearance for the SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB, a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB), submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on April 8, 1992, 68 days after receiving the submission on January 31, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K920416 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1992
Decision Date April 08, 1992
Days to Decision 68 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LIB — Device, General Purpose, Microbiology, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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