The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Aptima Combo 2 Assay.
| Device ID | K111409 |
| 510k Number | K111409 |
| Device Name: | APTIMA COMBO 2 ASSAY |
| Classification | Dna-reagents, Neisseria |
| Applicant | GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
| Contact | Jody J Fleming |
| Correspondent | Jody J Fleming GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
| 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 | 2011-05-19 |
| Decision Date | 2012-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045504141 | K111409 | 000 |
| 15420045500280 | K111409 | 000 |
| 15420045500273 | K111409 | 000 |