KULTSURE— 510(k) K870231
Substantially EquivalentNcs Diagnostics, Inc.
FDA 510(k) clearance K870231 for KULTSURE, Substantially Equivalent on 1987-02-04. Applicant: Ncs Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Ncs Diagnostics, Inc.
- Product code
- Code LIO
- Device class
- Class 1
- Regulation
- 21 CFR 866.2900
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, L4z 1y6, CA
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