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FDA 510(k), K172783, Access hs Tnl
FDA 510(k), K172783, Access hs Tnl
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510(K) Number: K172783
Device Name: Access hs Tnl
Manufacturer: Beckman Coulter, Inc.
Device Classification Name: immunoassay method, troponin subunit
Regulation Number: 862.1215
Classification Product Code: MMI
Date Received: 09/15/2017
Decision Date: 06/12/2018
Regulation Medical Specialty: Clinical Chemistry
Device Name: Access hs Tnl
Manufacturer: Beckman Coulter, Inc.
Device Classification Name: immunoassay method, troponin subunit
Regulation Number: 862.1215
Classification Product Code: MMI
Date Received: 09/15/2017
Decision Date: 06/12/2018
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
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