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FDA 510(k), K133343, WONDFO RAPID STREP A TEST
FDA 510(k), K133343, WONDFO RAPID STREP A TEST
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$149.00 USD
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510(K) Number: K133343
Device Name: WONDFO RAPID STREP A TEST
Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Device Classification Name: antigens, all groups, streptococcus spp.
Regulation Number: 866.3740
Classification Product Code: GTY
Date Received: 10/30/2013
Decision Date: 01/31/2014
Regulation Medical Specialty: Microbiology
Device Name: WONDFO RAPID STREP A TEST
Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Device Classification Name: antigens, all groups, streptococcus spp.
Regulation Number: 866.3740
Classification Product Code: GTY
Date Received: 10/30/2013
Decision Date: 01/31/2014
Regulation Medical Specialty: Microbiology
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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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