NUCLEOTOME PROBE SET, MODEL 21200
FDA 510(k) clearance K040919 · decided 2004-06-01
Clearance details
- K-number
- K040919
- Device name
- NUCLEOTOME PROBE SET, MODEL 21200
- Applicant
- Clarus Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2004-04-08
- Decision date
- 2004-06-01
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| i-STAT EC8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro qua recall (Z-1795-2010) | Abbott Point of Care Inc. | 2010-06-11 |