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510(k) K972265

A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER by Tosoh Medics, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1997
Date Received
June 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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