The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Aptima Combo 2 Assay (panther System), Aptima Combo 2 Assay (tigris) System).
Device ID | K200866 |
510k Number | K200866 |
Device Name: | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) |
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 | Anila Tarte |
Correspondent | Anila Tarte Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
Product Code | QEP |
Subsequent Product Code | LSL |
Subsequent Product Code | MKZ |
CFR Regulation Number | 866.3393 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-01 |
Decision Date | 2020-05-17 |