AT HOME OVULATION TEST, MODEL 9032— 510(k) K021409
Substantially EquivalentPhamatech, Inc.
FDA 510(k) clearance K021409 for AT HOME OVULATION TEST, MODEL 9032, Substantially Equivalent on 2002-05-24. Applicant: Phamatech, Inc.. Device class: 1.
Clearance details
- Applicant
- Phamatech, 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
- Special
- Location
- San Diego, CA, US
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