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510(k) K913384

COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 by Helena Laboratories — Product Code JPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1991
Date Received
July 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A2 Quantitation
Device Class
Class II
Regulation Number
864.7400
Review Panel
HE
Submission Type

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