BACT/ALERT CSR— 510(k) K003104
Substantially EquivalentOrganon Teknika Corp.
FDA 510(k) clearance K003104 for BACT/ALERT CSR, Substantially Equivalent on 2000-10-20. Applicant: Organon Teknika Corp.. Device class: 1.
Clearance details
- Applicant
- Organon Teknika Corp.
- Product code
- Code LJF
- Device class
- Class 1
- Regulation
- 21 CFR 866.2560
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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