510(k) K120662
K120662 is an FDA 510(k) premarket notification submitted by Abaxis, Inc. for the device "PICCOLO HDL-CAPILLARY TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on April 24, 2012. The device falls under product code JHM (Colorimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Abaxis, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2012
- Date Received
- March 5, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetric Method, Lipoproteins
- Device Class
- Class I
- Regulation Number
- 862.1475
- Review Panel
- CH
- Submission Type