BACTOGEN-H. INFLUENZAE TYPE B— 510(k) K800493

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K800493 for BACTOGEN-H. INFLUENZAE TYPE B, Substantially Equivalent on 1980-04-04. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code GRO
Device class: Class 2
Regulation: 21 CFR 866.3300
Advisory panel: Microbiology
Date received: 1980-03-04
Decision date: 1980-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K802423 — PHADEBACT HAEMOPHILUS TEST1980-11-12

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