510(k) K022108
K022108 is an FDA 510(k) premarket notification submitted by Thermo Dma, Inc. for the device "THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050". The FDA issued a decision of Substantially Equivalent on July 25, 2002. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Thermo Dma, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2002
- Date Received
- June 28, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Multi-Analyte Mixture
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type