GREPAFLOXACIN, 5 MG, SENSI-DISC
FDA 510(k) clearance K974578 · decided 1998-02-23
Clearance details
- K-number
- K974578
- Device name
- GREPAFLOXACIN, 5 MG, SENSI-DISC
- Applicant
- Becton Dickinson Microbiology Systems
- Decision
- Substantially Equivalent
- Date received
- 1997-12-08
- Decision date
- 1998-02-23
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- 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
No recalls on record reference this clearance.