BERICHROM(R) ANTITHROMBIN III— 510(k) K883662

Name: FDA 510(k) clearance K883662
Creator: U.S. Food and Drug Administration
Published: 1988-11-23

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K883662 for BERICHROM(R) ANTITHROMBIN III, Substantially Equivalent on 1988-11-23. 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: 1988-08-26
Decision date: 1988-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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