QUALISYS PSA IMMUNOASSAY— 510(k) K990234

Name: FDA 510(k) clearance K990234
Creator: U.S. Food and Drug Administration
Published: 1999-07-08

Substantially Equivalent

Qualisys Diagnostics, Inc.

FDA 510(k) clearance K990234 for QUALISYS PSA IMMUNOASSAY, Substantially Equivalent on 1999-07-08. Applicant: Qualisys Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Qualisys Diagnostics, Inc.
Product code: Code LTJ
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1999-01-25
Decision date: 1999-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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