EXETRELUT— 510(k) K782066

Substantially Equivalent

Mcb Manufacturing Chemists, Inc.

FDA 510(k) clearance K782066 for EXETRELUT, Substantially Equivalent on 1979-01-03. Applicant: Mcb Manufacturing Chemists, Inc.. Device class: 1.

Clearance details

Applicant: Mcb Manufacturing Chemists, Inc.
Product code: Code KEA
Device class: Class 1
Regulation: 21 CFR 862.2230
Advisory panel: Clinical Chemistry
Date received: 1978-12-13
Decision date: 1979-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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