SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
FDA 510(k) clearance K041240 · decided 2004-06-02
Clearance details
- K-number
- K041240
- Device name
- SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
- Applicant
- Fertility Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-11
- Decision date
- 2004-06-02
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- NRF
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Cleveland, OH, 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 |
|---|---|---|
| QC-BEADS (K042750) | Bioscreen, Inc. | 2004-10-29 |
| QWIKCHECK-BEADS (K041600) | Medical Electronics Systems , Ltd. | 2004-07-27 |
Recalls involving this device
No recalls on record reference this clearance.