AMMONIA REAGENT SET— 510(k) K915707

Substantially Equivalent

Tech Intl. Co.

FDA 510(k) clearance K915707 for AMMONIA REAGENT SET, Substantially Equivalent on 1992-02-26. Applicant: Tech Intl. Co.. Device class: 1.

Clearance details

Applicant: Tech Intl. Co.
Product code: Code JIF
Device class: Class 1
Regulation: 21 CFR 862.1065
Advisory panel: Clinical Chemistry
Date received: 1991-11-29
Decision date: 1992-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester Hills, MI, US

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K183517 — Ammonia II2019-02-08
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K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGE2013-02-15
K062316 — DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE2006-09-06
K051114 — SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY2005-11-25

More clearances from Tech Intl. Co.

K915704 — AMYLASE (KINETIC) REAGENT SET1996-06-28
K915705 — ACID PHOSPHATASE REAGENT SET1992-02-27
K914158 — URIC ACID REAGENT SET1992-02-21
K915706 — LIPASE REAGENT SET1992-02-18
K914160 — CHOLESTEROL REGEANT SET1992-01-30

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