HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM— 510(k) K820192

Name: FDA 510(k) clearance K820192
Creator: U.S. Food and Drug Administration
Published: 1982-03-11

Substantially Equivalent

Hyland Therapeutic Div., Travenol Laboratories

FDA 510(k) clearance K820192 for HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM, Substantially Equivalent on 1982-03-11. Applicant: Hyland Therapeutic Div., Travenol Laboratories. Device class: 2.

Clearance details

Applicant: Hyland Therapeutic Div., Travenol Laboratories
Product code: Code GRP
Device class: Class 2
Regulation: 21 CFR 866.3300
Advisory panel: Microbiology
Date received: 1982-01-25
Decision date: 1982-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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