BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB— 510(k) K961024
Substantially EquivalentPrinceton BioMeditech Corp.
FDA 510(k) clearance K961024 for BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB, Substantially Equivalent on 1997-02-04. Applicant: Princeton BioMeditech Corp.. Device class: 2.
Clearance details
- Applicant
- Princeton BioMeditech 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
- Monmouth Junction, NJ, US
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