QUANTA LITE TPO ELISA— 510(k) K981857

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K981857 for QUANTA LITE TPO ELISA, Substantially Equivalent on 1998-07-29. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1998-05-27
Decision date: 1998-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.