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510(k) K811189

CHEMSTRIP L by Biodynamics Corp. — Product Code GHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1981
Date Received
April 29, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Leukocyte Alkaline Phosphatase
Device Class
Class I
Regulation Number
864.7660
Review Panel
HE
Submission Type

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