The following data is part of a premarket notification filed by Abbott Molecular, Inc. with the FDA for Abbott Realtime Ct/ng And Abbott Multi-collect Specimen Collection Kit, Models 8l07-91, 9k12-03.
| Device ID | K092704 |
| 510k Number | K092704 |
| Device Name: | ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 |
| Classification | Dna-reagents, Chlamydia |
| Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Contact | Paula Martin |
| Correspondent | Paula Martin ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Product Code | LSK |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-03 |
| Decision Date | 2010-05-28 |
| Summary: | summary |