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510(k) K012525

THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 by Thermo Dma, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2001
Date Received
August 6, 2001
Clearance Type
Abbreviated
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

Other clearances by Thermo Dma, Inc.

  • K022108 — THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 (July 25, 2002)
  • K012878 — THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 (October 16, 2001)
  • K012518 — TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 (October 9, 2001)

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