IMMUNOCORP LH IRMA COATED TUBE— 510(k) K903052

Name: FDA 510(k) clearance K903052
Creator: U.S. Food and Drug Administration
Published: 1990-08-29

Substantially Equivalent

Immunocorp Sciences, Inc.

FDA 510(k) clearance K903052 for IMMUNOCORP LH IRMA COATED TUBE, Substantially Equivalent on 1990-08-29. Applicant: Immunocorp Sciences, Inc.. Device class: 1.

Clearance details

Applicant: Immunocorp Sciences, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1990-07-11
Decision date: 1990-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal (Quebec), CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.