QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA— 510(k) K021648

Name: FDA 510(k) clearance K021648
Creator: U.S. Food and Drug Administration
Published: 2002-09-20

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K021648 for QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA, Substantially Equivalent on 2002-09-20. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code NJF
Device class: Class 2
Regulation: 21 CFR 866.5120
Advisory panel: Immunology
Date received: 2002-05-20
Decision date: 2002-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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