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QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA

DEN000007 Class II Post-NSE
Decision Date
2000-08-16
Sponsor / Applicant
Inova Diagnostics, Inc.

Technical Specification

510(k) Submission ID DEN000007
Product Code NBT
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5785
Decision Date 2000-08-16
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA received FDA 510(k) clearance under submission number DEN000007, sponsored by Inova Diagnostics, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2000-08-16.

Classification & Regulation

This clearance is catalogued under FDA product code NBT and 21 CFR 866.5785, within the Immunology review panel as a Class II device.