QUANTRX FEMALE FERTILITY TEST
FDA 510(k) clearance K070484 · decided 2007-10-22
Clearance details
- K-number
- K070484
- Device name
- QUANTRX FEMALE FERTILITY TEST
- Applicant
- Quantrx Biomedical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-02-20
- Decision date
- 2007-10-22
- Days to decision
- 244 days
- Clearance type
- Traditional
- Product code
- NGA
- Device class
- 1
- Regulation number
- 862.1300
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, 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 |
|---|---|---|
| FERTELL FEMALE FERTILITY TEST (K032002) | Genosis, Inc. | 2003-10-30 |
Recalls involving this device
No recalls on record reference this clearance.