PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT— 510(k) K800398

Name: FDA 510(k) clearance K800398
Creator: U.S. Food and Drug Administration
Published: 1980-03-12

Substantially Equivalent

Diagnostica, Inc.

FDA 510(k) clearance K800398 for PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT, Substantially Equivalent on 1980-03-12. Applicant: Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostica, Inc.
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1980-02-26
Decision date: 1980-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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