FDA 510(k) Applications for Medical Device Product Code "JBF"
(Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening)

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


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