The following data is part of a premarket notification filed by Abbott Molecular, Inc. with the FDA for Abbott Multi-collect Specimen Collection Kit, Abbott Real Time Ct/ng.
| Device ID | K140354 |
| 510k Number | K140354 |
| Device Name: | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG |
| Classification | Dna-reagents, Neisseria |
| Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Contact | Stacy Ferguson |
| Correspondent | Stacy Ferguson ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Product Code | LSL |
| Subsequent Product Code | LIO |
| Subsequent Product Code | MKZ |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-12 |
| Decision Date | 2014-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884999046522 | K140354 | 000 |
| 20884999046515 | K140354 | 000 |
| 00884999037410 | K140354 | 000 |
| 00884999037298 | K140354 | 000 |
| 00884999037113 | K140354 | 000 |
| 00884999031142 | K140354 | 000 |
| 00884999031128 | K140354 | 000 |