The following data is part of a premarket notification filed by Hologic / Gen-probe Incorporated with the FDA for Aptima Combo 2 Assay (panther System).
| Device ID | K132251 |
| 510k Number | K132251 |
| Device Name: | APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) |
| Classification | Dna-reagents, Neisseria |
| Applicant | HOLOGIC / GEN-PROBE INCORPORATED 10210 GENETIC CENTER DRIVE San Diego, CA 92121 -4376 |
| Product Code | LSL |
| Subsequent Product Code | MKZ |
| Subsequent Product Code | NSU |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-19 |
| Decision Date | 2013-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045506442 | K132251 | 000 |
| 15420045506435 | K132251 | 000 |
| 15420045506244 | K132251 | 000 |
| 15420045505711 | K132251 | 000 |
| 15420045505704 | K132251 | 000 |
| 15420045505360 | K132251 | 000 |
| 15420045505353 | K132251 | 000 |
| 15420045511842 | K132251 | 000 |
| 15420045511835 | K132251 | 000 |