BACTIGEN(R) N. MENINGITIDIS— 510(k) K885004

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K885004 for BACTIGEN(R) N. MENINGITIDIS, Substantially Equivalent on 1989-02-07. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code GTJ
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1988-12-01
Decision date: 1989-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, 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.