THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES— 510(k) K973203

Name: FDA 510(k) clearance K973203
Creator: U.S. Food and Drug Administration
Published: 1998-09-30

Substantially Equivalent

Sangstat Medical Corp.

FDA 510(k) clearance K973203 for THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES, Substantially Equivalent on 1998-09-30. Applicant: Sangstat Medical Corp.. Device class: 2.

Clearance details

Applicant: Sangstat Medical Corp.
Product code: Code DAK
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 1997-08-26
Decision date: 1998-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

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