1
/
of
0
FDA 510(k), K080057, IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL
FDA 510(k), K080057, IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
510(K) Number: K080057
Device Name: IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL
Manufacturer: THOMAS TSAKERIS
Device Classification Name: Enzyme Immunoassay, Amphetamine
Regulation Number: DKZ
Classification Product Code: 01/09/2008
Date Received: 10/31/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL
Manufacturer: THOMAS TSAKERIS
Device Classification Name: Enzyme Immunoassay, Amphetamine
Regulation Number: DKZ
Classification Product Code: 01/09/2008
Date Received: 10/31/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Couldn't load pickup availability
- 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.
View full details