SERATEST ENA(RNP/SM) DETERMINATION— 510(k) K844743

Name: FDA 510(k) clearance K844743
Creator: U.S. Food and Drug Administration
Published: 1985-02-04

Substantially Equivalent

Seragen Diagnostics, Inc.

FDA 510(k) clearance K844743 for SERATEST ENA(RNP/SM) DETERMINATION, Substantially Equivalent on 1985-02-04. Applicant: Seragen Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Seragen Diagnostics, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1984-12-05
Decision date: 1985-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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