1
/
of
0
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
Regular price
$89.00 USD
Regular price
Sale price
$89.00 USD
Unit price
/
per
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: KXA
Date Received: 03/22/2006
Decision Date: 04/21/2006
Decision: 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: KXA
Date Received: 03/22/2006
Decision Date: 04/21/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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.
View full details