FDA 510(k) Applications for Medical Device:
Whole Blood Hemoglobin Determination
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K042379 | BIOSAFE LABORATORIES, INC. |
100 FIELD DRIVE #240 | LAKE FOREST | IL | 60045 |
| K001462 | CARESIDE, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K020138 | GDS TECHNOLOGY |
25235 LEER DR. | ELKHART | IN | 46514 |
| K973649 | GDS TECHNOLOGY, LLC. |
25235 LEER DR. | ELKHART | IN | 46514 |
| K994073 | GDS TECHNOLOGY, LLC. |
25235 LEER DR. | ELKHART | IN | 46515 |
| K221508 | Sanguina, Inc. |
147 Technology Parkway Ste 100 | Peachtree Corners | GA | 30092 |
| K163215 | SANGUINA, LLC |
575 14TH STREET | ATLANTA | GA | 30318 |
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