ENZYGNOST(R) TAT REAGENTS— 510(k) K880700

Name: FDA 510(k) clearance K880700
Creator: U.S. Food and Drug Administration
Published: 1988-04-27

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K880700 for ENZYGNOST(R) TAT REAGENTS, Substantially Equivalent on 1988-04-27. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1988-02-22
Decision date: 1988-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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