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FDA 510(k), K132066, INFLAMMA DRY
FDA 510(k), K132066, INFLAMMA DRY
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510(K) Number: K132066
Device Name: INFLAMMA DRY
Manufacturer: Douglas Bueschel
Device Classification Name: Mmp-9 Test System
Regulation Number: PFQ
Classification Product Code: KXA
Date Received: 07/03/2013
Decision Date: 11/21/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: INFLAMMA DRY
Manufacturer: Douglas Bueschel
Device Classification Name: Mmp-9 Test System
Regulation Number: PFQ
Classification Product Code: KXA
Date Received: 07/03/2013
Decision Date: 11/21/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- 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.
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