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510(k) K913091

BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY by American Laboratory Products Co., Ltd. — Product Code KQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1991
Date Received
July 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Angiotensin Converting Enzyme
Device Class
Class II
Regulation Number
862.1090
Review Panel
CH
Submission Type

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