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510(k) K972706

CLINITEK MICROALBUMIN REAGENT STRIPS by Bayer Corp. — Product Code CJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1997
Date Received
July 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tetrabromo-M-Cresolsulfonphthalein, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

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