FERTELL FEMALE FERTILITY TEST
FDA 510(k) clearance K032002 · decided 2003-10-30
Clearance details
- K-number
- K032002
- Device name
- FERTELL FEMALE FERTILITY TEST
- Applicant
- Genosis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-27
- Decision date
- 2003-10-30
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- NGA
- Device class
- 1
- Regulation number
- 862.1300
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QUANTRX FEMALE FERTILITY TEST (K070484) | Quantrx Biomedical Corporation | 2007-10-22 |
Recalls involving this device
No recalls on record reference this clearance.