FDA 510(k), K003987, URS-1K (KETONE TESST)

FDA 510(k), K003987, URS-1K (KETONE TESST)

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510(K) Number: K003987
Device Name: URS-1K (KETONE TESST)
Manufacturer:
Device Classification Name: Nitroprusside, Ketones (Urinary, Non-Quant.)
Regulation Number: 862.1435
Classification Product Code: JIN
Date Received: 12/26/2000
Decision Date: 04/26/2001
Regulation Medical Specialty: Clinical Chemistry
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