CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L
FDA 510(k) clearance K003533 · decided 2001-02-07
Clearance details
- K-number
- K003533
- Device name
- CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L
- Applicant
- Steritec Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-16
- Decision date
- 2001-02-07
- Days to decision
- 83 days
- Clearance type
- Abbreviated
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Castle Rock, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.