FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST— 510(k) K883530
Substantially EquivalentTambrands, Inc.
FDA 510(k) clearance K883530 for FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST, Substantially Equivalent on 1988-12-19. Applicant: Tambrands, Inc.. Device class: 1.
Clearance details
- Applicant
- Tambrands, Inc.
- 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
- Palmer, MA, US
Recent devices under product code CEP
view allMore clearances from Tambrands, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.