ANTI-HUMAN GLOBULINS— 510(k) K791285

Substantially Equivalent

Diagnostica, Inc.

FDA 510(k) clearance K791285 for ANTI-HUMAN GLOBULINS, Substantially Equivalent on 1979-10-17. 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: 1979-07-10
Decision date: 1979-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.