BIOSURE— 510(k) K840848

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K840848 for BIOSURE, Substantially Equivalent on 1984-05-01. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJW
Advisory panel: Clinical Chemistry
Date received: 1984-02-24
Decision date: 1984-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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