510(k) K895952
K895952 is an FDA 510(k) premarket notification submitted by Elite Technology, Inc. for the device "TRIGLYCERIDES TEST KIT". The FDA issued a decision of Substantially Equivalent on Jan 11, 1990. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Elite Technology, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 1990
- Date Received
- Oct 11, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- Device Class
- Class I
- Regulation Number
- 862.1705
- Review Panel
- CH
- Submission Type
- 510(k) Exempt