HYTEC AUTOIMMUNE KIT (JO-1)— 510(k) K954895

Name: FDA 510(k) clearance K954895
Creator: U.S. Food and Drug Administration
Published: 1996-03-20

Substantially Equivalent

Hycor Biomedical, Inc.

FDA 510(k) clearance K954895 for HYTEC AUTOIMMUNE KIT (JO-1), Substantially Equivalent on 1996-03-20. Applicant: Hycor Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Hycor Biomedical, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1995-10-25
Decision date: 1996-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

Download summary PDF View on FDA.gov ↗

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