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FDA 510(k), K050235, IQ 200 URINE ANALYZER BODY FLUIDS MODULE
FDA 510(k), K050235, IQ 200 URINE ANALYZER BODY FLUIDS MODULE
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510(K) Number: K050235
Device Name: IQ 200 URINE ANALYZER BODY FLUIDS MODULE
Manufacturer: HARVEY L KASDAN
Device Classification Name: Counter, Cell, Automated (Particle Counter)
Regulation Number: GKL
Classification Product Code: 02/01/2005
Date Received: 03/23/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: IQ 200 URINE ANALYZER BODY FLUIDS MODULE
Manufacturer: HARVEY L KASDAN
Device Classification Name: Counter, Cell, Automated (Particle Counter)
Regulation Number: GKL
Classification Product Code: 02/01/2005
Date Received: 03/23/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
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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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