The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Aptima Combo 2 Assay (panther) - 250 Test Kit, Aptima Combo 2 Assay (tigris) - 250 Test Kit, Aptima Trichomonas Vaginalis (panther) - 250 Test Kit, Aptima Trichomonas Vaginalis (tigris) - 250 Test Kit.
| Device ID | K200436 |
| 510k Number | K200436 |
| Device Name: | Aptima Combo 2 Assay (Panther) - 250 Test Kit, Aptima Combo 2 Assay (Tigris) - 250 Test Kit, Aptima Trichomonas Vaginalis (Panther) - 250 Test Kit, Aptima Trichomonas Vaginalis (Tigris) - 250 Test Kit |
| Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Applicant | Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
| Contact | Jill Wyland |
| Correspondent | Jill Wyland Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
| Product Code | QEP |
| Subsequent Product Code | LSL |
| Subsequent Product Code | MKZ |
| Subsequent Product Code | OUY |
| CFR Regulation Number | 866.3393 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-24 |
| Decision Date | 2020-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045515017 | K200436 | 000 |
| 15420045515000 | K200436 | 000 |
| 15420045514997 | K200436 | 000 |
| 15420045514980 | K200436 | 000 |
| 15420045514973 | K200436 | 000 |
| 15420045514966 | K200436 | 000 |