STAT-CRIT HEMATOCRIT MEASURING INSTRU
FDA 510(k) clearance K802199 · decided 1981-02-04
Clearance details
- K-number
- K802199
- Device name
- STAT-CRIT HEMATOCRIT MEASURING INSTRU
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1980-09-10
- Decision date
- 1981-02-04
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- GKF
- Device class
- 2
- Regulation number
- 864.5600
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.