PATHROMTIN SL— 510(k) K955450

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K955450 for PATHROMTIN SL, Substantially Equivalent on 1996-04-19. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1995-11-29
Decision date: 1996-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.