MYOSURE INTRUMENT TRAY
FDA 510(k) clearance K121280 · decided 2013-02-08
Clearance details
- K-number
- K121280
- Device name
- MYOSURE INTRUMENT TRAY
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-30
- Decision date
- 2013-02-08
- Days to decision
- 284 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Malborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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| Aptima HBV Quant Assay (P170025/S022) | Hologic, Inc. | 2024-10-23 |