FLUOR. CONJUGATED ANTISERUM— 510(k) K770484

Name: FDA 510(k) clearance K770484
Creator: U.S. Food and Drug Administration
Published: 1977-03-21

Substantially Equivalent

Kent Laboratories, Inc.

FDA 510(k) clearance K770484 for FLUOR. CONJUGATED ANTISERUM, Substantially Equivalent on 1977-03-21. Applicant: Kent Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kent Laboratories, Inc.
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1977-03-14
Decision date: 1977-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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