The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Aptima Herpes Simplex Viruses 1 & 2 Assay.
| Device ID | K162673 |
| 510k Number | K162673 |
| Device Name: | Aptima Herpes Simplex Viruses 1 & 2 Assay |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Applicant | HOLOGIC, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 |
| Contact | Ron Domingo |
| Correspondent | Ron Domingo HOLOGIC, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 |
| Product Code | OQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2017-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045507234 | K162673 | 000 |
| 15420045507227 | K162673 | 000 |
| 15420045507210 | K162673 | 000 |