The following data is part of a premarket notification filed by Abbott Molecular, Inc. with the FDA for Abbott Realtime Ct/ng Assay And Multi-collect Specimen Collection Kit.
| Device ID | K080739 |
| 510k Number | K080739 |
| Device Name: | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT |
| Classification | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Contact | Paula E Martin |
| Correspondent | Paula E Martin ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Product Code | MKZ |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-17 |
| Decision Date | 2008-07-10 |
| Summary: | summary |