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 |
| K201049 | Baebies, Inc. |
615 Davis Drive | Morrisville | NC | 27560 |
| K080003 | BINAX, INC. |
10 SOUTHGATE RD. | SCARBOROUGH | ME | 04074 |
| K024006 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
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