Cleared Traditional

TINAQUANT B 2-MICROGLOBULIN ASSAY

K980724 · Boehringer Mannheim Corp. · Immunology
Oct 1998
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K980724 is an FDA 510(k) clearance for the TINAQUANT B 2-MICROGLOBULIN ASSAY, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on October 16, 1998, 234 days after receiving the submission on February 24, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K980724 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1998
Decision Date October 16, 1998
Days to Decision 234 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZG — System, Test, Beta-2-microglobulin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5630

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