Cleared Traditional

BOEHRINGER MANNHEIM TINA-QUANT IGE TEST

K983185 · Boehringer Mannheim Corp. · Immunology
Nov 1998
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K983185 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM TINA-QUANT IGE TEST, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on November 12, 1998, 62 days after receiving the submission on September 11, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K983185 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1998
Decision Date November 12, 1998
Days to Decision 62 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DGC — Ige, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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