Enzynatic Triglycerides Reagent Set
510(k) K855164
Enzynatic Triglycerides Reagent Set is a Class I device made by Sterling Diagnostics Inc, cleared under FDA 510(k) K855164 on 19 Feb 1986, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK855164 | Date19 Feb 1986 | StatusActive |
Official records
- FDA 510(k) database K855164
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CDT
- FDA applicant
- Sterling Diagnostics, Inc.
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1705
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides).
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