510(k) K915464
K915464 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "DIGITOXIN FPIA CALIBRATOR SET". The FDA issued a decision of Substantially Equivalent on Jan 15, 1992. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 15, 1992
- Date Received
- Dec 2, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Calibrators, Drug Specific
- Device Class
- Class II
- Regulation Number
- 862.3200
- Review Panel
- TX
- Submission Type
- 510(k) Exempt