510(k) K974262
K974262 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "SYSCOS IDC - G, IDC, BSC, IDC - G". The FDA issued a decision of Substantially Equivalent on December 24, 1997. The device falls under product code MJX (Kit, Serological, Positive Control), a Class I device regulated under 21 CFR 862.1660. Scantibodies Laboratory, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 24, 1997
- Date Received
- November 13, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Serological, Positive Control
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- MI
- Submission Type