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FDA 510(k), K913943, SERIM DISINTEK REAGENT STRIPS
FDA 510(k), K913943, SERIM DISINTEK REAGENT STRIPS
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510(K) Number: K913943
Device Name: SERIM DISINTEK REAGENT STRIPS
Manufacturer: MICHAEL MCKENNA
Device Classification Name: Sterilant, Medical Devices
Regulation Number: MED
Classification Product Code: KXA
Date Received: 09/04/1991
Decision Date: 03/26/1992
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: SERIM DISINTEK REAGENT STRIPS
Manufacturer: MICHAEL MCKENNA
Device Classification Name: Sterilant, Medical Devices
Regulation Number: MED
Classification Product Code: KXA
Date Received: 09/04/1991
Decision Date: 03/26/1992
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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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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