FDA 510(k) Applications for Medical Device:
Electrophoretic Separation, Lipoproteins
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K960571 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K962914 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K992971 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K980650 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K964471 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K013466 | HELENA LABORATORIES |
P.O. BOX 752 | BEAUMONT | TX | 77704 |
| K000603 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K022333 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K974854 | MORAX |
13805 WATERLOO RD. | CHELSEA | MI | 48118 |
| K012789 | MORAX |
13805 WATERLOO RD. | CHELSEA | MI | 48118 |
| K010337 | QUANTIMETRIX CORP. |
2005 MANHATTAN BEACH BLVD. | REDONDO BEACH | CA | 90278-1205 |
| K013662 | QUANTIMETRIX CORP. |
2005 MANHATTAN BEACH BLVD. | REDONDO BEACH | CA | 90278-1205 |
| K022053 | SEBIA |
13805 WATERLOO | CHELSEA | MI | 48118 |
| K971157 | STRATEGIC DIAGNOSTICS, INC. |
128 SANDY DR. | NEWARK | DE | 19713 |
| K960785 | ZAXIS, INC. |
1890 GEORGETOWN RD. | HUDSON | OH | 44236 |
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