QWIKCHECK-BEADS
FDA 510(k) clearance K041600 · decided 2004-07-27
Clearance details
- K-number
- K041600
- Device name
- QWIKCHECK-BEADS
- Applicant
- Medical Electronics Systems , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-14
- Decision date
- 2004-07-27
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- NRF
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Los Angeles, 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 |
|---|---|---|
| QC-BEADS (K042750) | Bioscreen, Inc. | 2004-10-29 |
| SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED (K041240) | Fertility Solutions, Inc. | 2004-06-02 |
Recalls involving this device
No recalls on record reference this clearance.