IMMUNO-CEPT D (BETA-MONOCLONAL)— 510(k) K863741

Name: FDA 510(k) clearance K863741
Creator: U.S. Food and Drug Administration
Published: 1986-11-13

Substantially Equivalent

Immunostics Co., Inc.

FDA 510(k) clearance K863741 for IMMUNO-CEPT D (BETA-MONOCLONAL), Substantially Equivalent on 1986-11-13. Applicant: Immunostics Co., Inc.. Device class: 2.

Clearance details

Applicant: Immunostics Co., Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1986-09-23
Decision date: 1986-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ocean, NJ, US

Download summary PDF View on FDA.gov ↗

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