LIPASE REAGENT SET— 510(k) K915706

Substantially Equivalent

Tech Intl. Co.

FDA 510(k) clearance K915706 for LIPASE REAGENT SET, Substantially Equivalent on 1992-02-18. Applicant: Tech Intl. Co.. Device class: 1.

Clearance details

Applicant: Tech Intl. Co.
Product code: Code CET
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1991-11-29
Decision date: 1992-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester Hills, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CET

K970124 — LIPASE REAGENT SET (COLIPASE METHOD)1997-03-06
K940457 — LIPASE REAGENT SYSTEM1994-06-02
K901858 — MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST1990-06-12
K893718 — DELTATEST (R) LIPASE II1989-09-28
K885078 — LIPASE SR LIQUID STABLE REAGENT SET1989-03-13

More clearances from Tech Intl. Co.

K915704 — AMYLASE (KINETIC) REAGENT SET1996-06-28
K915705 — ACID PHOSPHATASE REAGENT SET1992-02-27
K915707 — AMMONIA REAGENT SET1992-02-26
K914158 — URIC ACID REAGENT SET1992-02-21
K914160 — CHOLESTEROL REGEANT SET1992-01-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.