Product code CET— Clinical Chemistry
LIPASE REAGENT SET
- Classification name
- Olive Oil Emulsion (Turbidimetric), Lipase
- Device class
- Class 1
- Regulation
- 21 CFR 862.1465
- Advisory panel
- Clinical Chemistry
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code CET
FDA has cleared devices under product code CET between 1977 and 1997, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1997
- 1994
- 1992
- 1990
- 1989
- 1987
- 1986
- 1985
- 1983
- 1981
- 1979
- 1977
Top applicants under product code CET
Recent clearances under product code CET
- K970124 — LIPASE REAGENT SET (COLIPASE METHOD)
- K940457 — LIPASE REAGENT SYSTEM
- K915706 — LIPASE REAGENT SET
- K901858 — MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
- K893718 — DELTATEST (R) LIPASE II
- K885078 — LIPASE SR LIQUID STABLE REAGENT SET
- K864438 — BECKMAN EPSILON(TM) LIPASE TEST KIT
- K862440 — PARAMAX LIPASE REAGENT
- K844240 — ENZYGNOST LIPASE TEST
- K823860 — NUCLIPASE (I125) PANCREATIC LIPASE
- K812794 — LIPASE
- K792289 — LIPASE TEST KIT
- K791922 — HARLECO BRAND CLINICARD LIPASE TEST SET
- K790796 — LIPASE REAGENT SET
- K770364 — ACA LIPASE ANALYTICAL TEST PACK
Data sourced from openFDA. This site is unofficial and independent of the FDA.