RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2— 510(k) K031101

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K031101 for RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2, Substantially Equivalent on 2003-06-16. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2003-04-07
Decision date: 2003-06-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Columbia, MD, US

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