HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY— 510(k) K962727

Name: FDA 510(k) clearance K962727
Creator: U.S. Food and Drug Administration
Published: 1997-03-07

Substantially Equivalent

Hycor Biomedical, Inc.

FDA 510(k) clearance K962727 for HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY, Substantially Equivalent on 1997-03-07. 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: 1996-07-01
Decision date: 1997-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

Download summary PDF View on FDA.gov ↗

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