KULTSURE
FDA 510(k) clearance K871404 · decided 1987-04-21
Clearance details
- K-number
- K871404
- Device name
- KULTSURE
- Applicant
- Ncs Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-04-08
- Decision date
- 1987-04-21
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- JSM
- Device class
- 1
- Regulation number
- 866.2390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mississauga, L4z 1y6, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.