NEIA PAP ENZYMEIMMUNOASSAY— 510(k) K811757

Name: FDA 510(k) clearance K811757
Creator: U.S. Food and Drug Administration
Published: 1981-08-13

Substantially Equivalent

New England Immunology Assoc.

FDA 510(k) clearance K811757 for NEIA PAP ENZYMEIMMUNOASSAY, Substantially Equivalent on 1981-08-13. Applicant: New England Immunology Assoc.. Device class: 2.

Clearance details

Applicant: New England Immunology Assoc.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1981-06-22
Decision date: 1981-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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