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510(k) K991010

ACP by Abbott Diagnostics Mfg., Inc. — Product Code CKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1999
Date Received
March 26, 1999
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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