The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Probetec Chlamydia Trachomatis (ct) Q Amplified Dna Assay.
| Device ID | K081824 |
| 510k Number | K081824 |
| Device Name: | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY |
| Classification | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Kathryn B Carr |
| Correspondent | Kathryn B Carr BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Product Code | MKZ |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-27 |
| Decision Date | 2008-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904411268 | K081824 | 000 |