OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST— 510(k) K963693
Substantially EquivalentPrinceton BioMeditech Corp.
FDA 510(k) clearance K963693 for OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST, Substantially Equivalent on 1996-11-29. Applicant: Princeton BioMeditech Corp.. Device class: 1.
Clearance details
- Applicant
- Princeton BioMeditech Corp.
- Product code
- Code CEP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princeton, NJ, US
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