BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST— 510(k) K100817
Substantially EquivalentPrinceton BioMeditech Corp.
FDA 510(k) clearance K100817 for BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST, Substantially Equivalent on 2010-07-01. Applicant: Princeton BioMeditech Corp.. Device class: 2.
Clearance details
- Applicant
- Princeton BioMeditech Corp.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monmouth Junction, NJ, US
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