FDA 510(k) Applications for Medical Device Product Code "JBF"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K161364 | ALERE SCARBOROUGH, INC. | BinaxNOW G6PD Test | 06/17/2016 |
K201049 | Baebies, Inc. | FINDER G6PD | 09/14/2022 |
K080003 | BINAX, INC. | BINAXNOW G6PD TEST | 10/23/2008 |
K024006 | POINTE SCIENTIFIC, INC. | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | 03/31/2003 |