QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD— 510(k) K901453

Name: FDA 510(k) clearance K901453
Creator: U.S. Food and Drug Administration
Published: 1990-04-12

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K901453 for QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD, Substantially Equivalent on 1990-04-12. 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: 1990-03-27
Decision date: 1990-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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