The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Aptima Trichomonas Vaginalis Assay - Panther.
| Device ID | K122062 |
| 510k Number | K122062 |
| Device Name: | APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER |
| Classification | Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Applicant | GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
| Contact | Maria Carmelita S Baluyot |
| Correspondent | Maria Carmelita S Baluyot GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
| Product Code | OUY |
| CFR Regulation Number | 866.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-13 |
| Decision Date | 2013-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045505766 | K122062 | 000 |
| 15420045505452 | K122062 | 000 |
| 15420045505469 | K122062 | 000 |
| 15420045505476 | K122062 | 000 |
| 15420045505483 | K122062 | 000 |
| 15420045505490 | K122062 | 000 |
| 15420045505506 | K122062 | 000 |
| 15420045505513 | K122062 | 000 |
| 15420045505520 | K122062 | 000 |
| 15420045505537 | K122062 | 000 |
| 15420045505544 | K122062 | 000 |
| 15420045505551 | K122062 | 000 |
| 15420045505445 | K122062 | 000 |