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510(k) K012878

THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 by Thermo Dma, Inc. — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2001
Date Received
August 28, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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

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