ABUSCREEN ONLINE CONTROLS
FDA 510(k) clearance K945194 · decided 1994-12-09
Clearance details
- K-number
- K945194
- Device name
- ABUSCREEN ONLINE CONTROLS
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-24
- Decision date
- 1994-12-09
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- DIF
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Branchburg, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.