510(k) K023639
K023639 is an FDA 510(k) premarket notification submitted by Abaxis, Inc. for the device "PICCOLO TRIGLYCERIDES TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on January 24, 2003. The device falls under product code JGY (Colorimetric Method, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Abaxis, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 2003
- Date Received
- October 30, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetric Method, Triglycerides
- Device Class
- Class I
- Regulation Number
- 862.1705
- Review Panel
- CH
- Submission Type