QUIK-SEP IGM ISOLATION SYSTEM— 510(k) K830606

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K830606 for QUIK-SEP IGM ISOLATION SYSTEM, Substantially Equivalent on 1983-03-24. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1983-02-25
Decision date: 1983-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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