510(k) K923080
K923080 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST APOLIPOROTEIN B (APO B)". The FDA issued a decision of Substantially Equivalent on October 26, 1992. The device falls under product code MSJ (Apolipoproteins), a Class I device regulated under 21 CFR 862.1475. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 1992
- Date Received
- June 25, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apolipoproteins
- Device Class
- Class I
- Regulation Number
- 862.1475
- Review Panel
- CH
- Submission Type