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510(k) K881204

ACP KINETIC TEST (ACID PHOSPHATASE TEST) by Sclavo, Inc. — Product Code CKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1988
Date Received
March 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase, Naphthyl Phosphate
Device Class
Class II
Regulation Number
862.1020
Review Panel
CH
Submission Type

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  • K963640 — OLYMPUS ACID PHOSPHATASE REAGENT (February 18, 1997)
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