The following data is part of a premarket notification filed by Abbott Molecular, Inc. with the FDA for Alinity M Sti Assay.
| Device ID | K202977 |
| 510k Number | K202977 |
| Device Name: | Alinity M STI Assay |
| Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Applicant | Abbott Molecular, Inc. 1300 E. Touhy Des Plains, IL 60018 |
| Contact | Stacy Ferguson |
| Correspondent | Stacy Ferguson Abbott Molecular, Inc. 1300 E. Touhy Des Plains, IL 60018 |
| Product Code | QEP |
| Subsequent Product Code | LSL |
| Subsequent Product Code | MKZ |
| Subsequent Product Code | OOI |
| Subsequent Product Code | OUY |
| CFR Regulation Number | 866.3393 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-30 |
| Decision Date | 2022-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884999050410 | K202977 | 000 |
| 00884999048669 | K202977 | 000 |
| 00884999048607 | K202977 | 000 |
| 00884999048591 | K202977 | 000 |