MONODEX— 510(k) K894793
Substantially EquivalentCenogenics Corp.
FDA 510(k) clearance K894793 for MONODEX, Substantially Equivalent on 1989-08-21. Applicant: Cenogenics Corp.. Device class: 2.
Clearance details
- Applicant
- Cenogenics Corp.
- Product code
- Code KTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5640
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morganville, NJ, US
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