BACTIGEN(R) GROUP B STREPTOCOCCUS TEST— 510(k) K885003

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K885003 for BACTIGEN(R) GROUP B STREPTOCOCCUS TEST, Substantially Equivalent on 1989-02-07. Applicant: Armkel, LLC.

Clearance details

Applicant: Armkel, LLC
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 1988-12-01
Decision date: 1989-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

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