ENZYGNOST PLATELET FACTOR 4 (PF4) KIT— 510(k) K890633

Name: FDA 510(k) clearance K890633
Creator: U.S. Food and Drug Administration
Published: 1989-04-21

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K890633 for ENZYGNOST PLATELET FACTOR 4 (PF4) KIT, Substantially Equivalent on 1989-04-21. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code LCO
Device class: Class 2
Regulation: 21 CFR 864.7695
Advisory panel: Hematology
Date received: 1989-02-08
Decision date: 1989-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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