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FDA 510(k), K053253, HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
FDA 510(k), K053253, HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
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510(K) Number: K053253
Device Name: HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
Manufacturer: HEMOCUE AB
Device Classification Name: automated urinalysis system
Regulation Number: 862.2900
Classification Product Code: KQO
Date Received: 11/21/2005
Decision Date: 02/17/2006
Regulation Medical Specialty: Clinical Chemistry
Device Name: HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
Manufacturer: HEMOCUE AB
Device Classification Name: automated urinalysis system
Regulation Number: 862.2900
Classification Product Code: KQO
Date Received: 11/21/2005
Decision Date: 02/17/2006
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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