510(k) K844032
K844032 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "TRIGLYCERIDE REAGENT". The FDA issued a decision of Substantially Equivalent on Nov 9, 1984. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 9, 1984
- Date Received
- Oct 15, 1984
- 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