AMYLASE (KINETIC) REAGENT SET— 510(k) K915704

Substantially Equivalent

Tech Intl. Co.

FDA 510(k) clearance K915704 for AMYLASE (KINETIC) REAGENT SET, Substantially Equivalent on 1996-06-28. Applicant: Tech Intl. Co.. Device class: 2.

Clearance details

Applicant: Tech Intl. Co.
Product code: Code CJD
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1991-11-27
Decision date: 1996-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, US

Download summary PDF View on FDA.gov ↗

More clearances from Tech Intl. Co.

K915705 — ACID PHOSPHATASE REAGENT SET1992-02-27
K915707 — AMMONIA REAGENT SET1992-02-26
K914158 — URIC ACID REAGENT SET1992-02-21
K915706 — LIPASE REAGENT SET1992-02-18
K914160 — CHOLESTEROL REGEANT SET1992-01-30

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