BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
FDA 510(k) clearance K984631 · decided 1999-11-04
Clearance details
- K-number
- K984631
- Device name
- BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
- Applicant
- Becton Dickinson Microbiology Systems
- Decision
- Substantially Equivalent
- Date received
- 1998-12-30
- Decision date
- 1999-11-04
- Days to decision
- 309 days
- Clearance type
- Traditional
- Product code
- LSL
- Device class
- 2
- Regulation number
- 866.3390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson a recall (Z-2658-2011) | Becton Dickinson & Co. | 2011-06-24 |
| Becton Dickinson's ProbeTec (tm) ET Instrument recall (Z-1094-03) | Becton Dickinson & Co. | 2003-08-20 |