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510(k) K942497

ANGIOTENSIN CONVERTING ENZYME REA by American Laboratory Products Co., Ltd. — Product Code KQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1994
Date Received
May 17, 1994
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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