Cleared Traditional

QUANTA LITE RIBOSOME P ELISA

K981237 · Inova Diagnostics, Inc. · Immunology
Jun 1998
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K981237 is an FDA 510(k) clearance for the QUANTA LITE RIBOSOME P ELISA, a Anti-ribosomal P Antibodies (Class II — Special Controls, product code MQA), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 5, 1998, 63 days after receiving the submission on April 3, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K981237 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1998
Decision Date June 05, 1998
Days to Decision 63 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MQA — Anti-ribosomal P Antibodies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100