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 |
25420045510187 | K162673 | 000 |