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510(k) K883387

ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) by Tech-Co, Inc. — Product Code CKD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1988
Date Received
August 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hydrazone Colorimetry, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

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