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FDA 510(k), K102242, OSOM C. DIFFICILE TOXIN A/B TEST
FDA 510(k), K102242, OSOM C. DIFFICILE TOXIN A/B TEST
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510(K) Number: K102242
Device Name: OSOM C. DIFFICILE TOXIN A/B TEST
Manufacturer: GENZYME CORPORATION
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 08/09/2010
Decision Date: 12/21/2010
Regulation Medical Specialty: Microbiology
Device Name: OSOM C. DIFFICILE TOXIN A/B TEST
Manufacturer: GENZYME CORPORATION
Device Classification Name: reagents, clostridium difficile toxin
Regulation Number: 866.2660
Classification Product Code: LLH
Date Received: 08/09/2010
Decision Date: 12/21/2010
Regulation Medical Specialty: Microbiology
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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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