510(k) K944731
K944731 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT IMX 2 ANALYZER". The FDA issued a decision of Substantially Equivalent on December 19, 1994. The device falls under product code JJI (Analyzer, Enzyme, For Clinical Use), a Class I device regulated under 21 CFR 862.2500. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 1994
- Date Received
- September 12, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Enzyme, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2500
- Review Panel
- CH
- Submission Type