DRYSIDE NEISSERIA
FDA 510(k) clearance K954784 · decided 1996-01-30
Clearance details
- K-number
- K954784
- Device name
- DRYSIDE NEISSERIA
- Applicant
- Difco Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-17
- Decision date
- 1996-01-30
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- LTS
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Livouia, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.