The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Bdprobetec Et Chlamydia Trachomatis And Neisseria Gonorrhoeae Amplified Dna Assay.
| Device ID | K984631 |
| 510k Number | K984631 |
| Device Name: | BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY |
| Classification | Dna-reagents, Neisseria |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Colleen Rohrbeck |
| Correspondent | Colleen Rohrbeck BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Product Code | LSL |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-30 |
| Decision Date | 1999-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904407162 | K984631 | 000 |
| 30382902201428 | K984631 | 000 |
| 30382902201435 | K984631 | 000 |
| 00382904404505 | K984631 | 000 |
| 00382904404512 | K984631 | 000 |
| 00382904404536 | K984631 | 000 |
| 30382904404612 | K984631 | 000 |
| 00382904404741 | K984631 | 000 |
| 30382904404766 | K984631 | 000 |
| 00382904404789 | K984631 | 000 |
| 00382904404802 | K984631 | 000 |
| 00382904404833 | K984631 | 000 |
| 00382904404871 | K984631 | 000 |
| 00382904407049 | K984631 | 000 |
| 00382904407056 | K984631 | 000 |
| 30382904404520 | K984631 | 000 |