SERO/TEX RED CELL RF TEST— 510(k) K831597

Name: FDA 510(k) clearance K831597
Creator: U.S. Food and Drug Administration
Published: 1983-06-30

Substantially Equivalent

Texas Immunology, Inc.

FDA 510(k) clearance K831597 for SERO/TEX RED CELL RF TEST, Substantially Equivalent on 1983-06-30. Applicant: Texas Immunology, Inc.. Device class: 2.

Clearance details

Applicant: Texas Immunology, Inc.
Product code: Product code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1983-05-17
Decision date: 1983-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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