FDA 510(k) Applications for Medical Device:
Antigens, Nontreponemal, All
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K182391 | Arlington Scientific, Inc. (ASI) |
1840 North Technology Dr. | Springville | UT | 84663 |
| K201438 | Arlington Scientific, Inc. (ASI) |
1840 North Technology Dr. | Springville | UT | 84663 |
| K173376 | Arlington Scientific, Inc. (ASI) |
1840 North Technology Dr. | Springville | UT | 84663 |
| K992124 | AVANTI POLAR LIPIDS, INC. |
700 INDUSTRIAL PARK DR. | ALABASTER | AL | 35007-9105 |
| K000687 | BEACON BIOLOGICALS, INC. |
6004 GLENDALE DR. | BOCA RATON | FL | 33433 |
| K952802 | BIOMIRA DIAGNOSTICS, INC. |
30 MERIDIAN RD. | REXDALE, ONTARIO | M9W 4Z7 | |
| K993633 | CENTERS FOR DISEASE CONTROL AND PREVENTION |
1600 CLIFTON RD., N.E. | ATLANTA | GA | 30333 |
| K150358 | GOLD STANDARD DIAGNOSTICS |
2851 SPAFFORD | DAVIS | CA | 95618 |
| K954994 | GUARDIAN SCIENTIFIC, CORP. |
8990-E ROUTE 108 | COLUMBIA | MD | 21045 |
| K955136 | REMEL, L.P. |
P.O. BOX 16276 | AUGUSTA | GA | 30919-2276 |
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