510(k) K781746
K781746 is an FDA 510(k) premarket notification submitted by Catalyst Research Corp. for the device "MINICO". The FDA issued a decision of Substantially Equivalent on December 5, 1978. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430. Catalyst Research Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1978
- Date Received
- October 18, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1430
- Review Panel
- AN
- Submission Type