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FDA 510(k), K060768, PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
FDA 510(k), K060768, PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
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510(K) Number: K060768
Device Name: PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
Manufacturer: MARIA E TREJO
Device Classification Name: Nitroprusside, Ketones (Urinary, Non-Quant.)
Regulation Number: JIN
Classification Product Code: 03/22/2006
Date Received: 04/21/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
Manufacturer: MARIA E TREJO
Device Classification Name: Nitroprusside, Ketones (Urinary, Non-Quant.)
Regulation Number: JIN
Classification Product Code: 03/22/2006
Date Received: 04/21/2006
Decision Date: Substantially Equivalent (SESE)
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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