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510(k) K012518

TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 by Thermo Dma, Inc. — Product Code CJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2001
Date Received
August 6, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

Other clearances by Thermo Dma, Inc.

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  • K012525 — THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 (October 4, 2001)

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