T4 EIA BEAD ASSAY— 510(k) K920766

Substantially Equivalent

Tech-Co, Inc.

FDA 510(k) clearance K920766 for T4 EIA BEAD ASSAY, Substantially Equivalent on 1992-04-17. Applicant: Tech-Co, Inc.. Device class: 2.

Clearance details

Applicant: Tech-Co, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1992-02-19
Decision date: 1992-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester Hills, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Tech-Co, Inc.

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K902574 — POTASSIUM REAGENT SET1990-07-10
K901561 — IRON/TOTAL IRON BINDING CAPACITY1990-05-17

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