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FDA 510(k), K011568, RANDOX LIPOPROTEIN
FDA 510(k), K011568, RANDOX LIPOPROTEIN
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510(K) Number: K011568
Device Name: RANDOX LIPOPROTEIN
Manufacturer: RANDOX LABORATORIES, LTD.
Device Classification Name: calibrator, primary
Regulation Number: 862.1150
Classification Product Code: JIS
Date Received: 05/21/2001
Decision Date: 09/28/2001
Regulation Medical Specialty: Clinical Chemistry
Device Name: RANDOX LIPOPROTEIN
Manufacturer: RANDOX LABORATORIES, LTD.
Device Classification Name: calibrator, primary
Regulation Number: 862.1150
Classification Product Code: JIS
Date Received: 05/21/2001
Decision Date: 09/28/2001
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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