QUANTA LITE(TM) THYROID M ELISA— 510(k) K930485

Name: FDA 510(k) clearance K930485
Creator: U.S. Food and Drug Administration
Published: 1993-03-16

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K930485 for QUANTA LITE(TM) THYROID M ELISA, Substantially Equivalent on 1993-03-16. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1993-01-29
Decision date: 1993-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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