SYSCOS IDC - G, IDC, BSC, IDC - G
FDA 510(k) clearance K974262 · decided 1997-12-24
Clearance details
- K-number
- K974262
- Device name
- SYSCOS IDC - G, IDC, BSC, IDC - G
- Applicant
- Scantibodies Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-13
- Decision date
- 1997-12-24
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- MJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santee, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.