510(k) K885134
K885134 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, Inc. for the device "CLINISTAT TRIGLYCERIDES REAGENT TEST". The FDA issued a decision of Substantially Equivalent on February 10, 1989. The device falls under product code JGY (Colorimetric Method, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Heraeus Kulzer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1989
- Date Received
- December 12, 1988
- 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