FDA 510(k) Applications for Medical Device:
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K161364 ALERE SCARBOROUGH, INC. 10 SOUTHGATE ROAD
Scarborough ME 04074
K080003 BINAX, INC. 10 SOUTHGATE RD.
SCARBOROUGH ME 04074
K024006 POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR.
LINCOLN PARK MI 48146
K933934 SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE.
ST. LOUIS MO 63103




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