510(k) K920109
K920109 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "IMX INSULIN". The FDA issued a decision of Substantially Equivalent on May 7, 1992. The device falls under product code CFP (Radioimmunoassay, Immunoreactive Insulin), a Class I device regulated under 21 CFR 862.1405. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 1992
- Date Received
- January 10, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Immunoreactive Insulin
- Device Class
- Class I
- Regulation Number
- 862.1405
- Review Panel
- CH
- Submission Type