FDA 510(k) Applications for Medical Device:
Abnormal Hemoglobin Quantitation
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K955355 | BIO-RAD |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547-1803 |
| K080911 | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547 |
| K051072 | BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547 |
| K171664 | Bio-Rad Laboratories, Inc. |
4000 Alfred Nobel Drive | Hercules | CA | 94547 |
| K192931 | Helena Laboratories, Corp. |
1530 Lingbergh Drive | Beaumont | TX | 77707 |
| K040146 | INTERLAB S.R.L. |
150 CHERRY LANE RD. | EAST STROUDSBURG | PA | 18301-8804 |
| K955283 | PRIMUS CORP. |
P.O. BOX 22599 | KANSAS CITY | MO | 64113 |
| K180762 | SEBIA |
1705 Corporate Drive, Suite 400 | Norcross | GA | 30093 |
| K052291 | SEBIA |
13805 WATERLOO | CHELSEA | MI | 48118 |
| K112550 | SEBIA |
400-1705 CORPORATE DRIVE | NORCROSS | GA | 30096 |
| K091283 | SEBIA |
1705 CORPORATE DRIVE | NORCROSS | GA | 30093 |
| K082227 | SEBIA |
400-1705 CORPORATE DRIVE | NORCROSS | GA | 30093 |
| K112491 | SEBIA |
PARC TECHNOLOGIQUE LEONARD DE | EVRY | 91008 | |
| K222635 | Trinity Biotech (Primus Corporation, dba Trinity Biotech) |
4231 E. 75th Terrace | Kansas City | MO | 64132 |
| K050709 | WALLAC OY |
MUSTIONKATU 6 | TURKU | 20750 |
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