HELENA HBA2 QUIK COLUMN METHOD— 510(k) K803108

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K803108 for HELENA HBA2 QUIK COLUMN METHOD, Substantially Equivalent on 1981-01-09. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JPD
Advisory panel: Hematology
Date received: 1980-12-10
Decision date: 1981-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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