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FDA 510(k), K012878, THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
FDA 510(k), K012878, THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
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510(K) Number: K012878
Device Name: THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
Manufacturer: THERMO DMA, INC.
Device Classification Name: calibrator, primary
Regulation Number: 862.1150
Classification Product Code: JIS
Date Received: 08/28/2001
Decision Date: 10/16/2001
Regulation Medical Specialty: Clinical Chemistry
Device Name: THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
Manufacturer: THERMO DMA, INC.
Device Classification Name: calibrator, primary
Regulation Number: 862.1150
Classification Product Code: JIS
Date Received: 08/28/2001
Decision Date: 10/16/2001
Regulation Medical Specialty: Clinical Chemistry
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