CHLAMYDIATROL AG— 510(k) K972129

Substantially Equivalent

Blackhawk Biosystems, Inc.

FDA 510(k) clearance K972129 for CHLAMYDIATROL AG, Substantially Equivalent on 1997-08-12. Applicant: Blackhawk Biosystems, Inc.. Device class: 1.

Clearance details

Applicant: Blackhawk Biosystems, Inc.
Product code: Code MJZ
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1997-06-06
Decision date: 1997-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

Download summary PDF View on FDA.gov ↗

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