Cleared Traditional

MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS

K903441 · Intl. Immunoassay Laboratories, Inc. · Chemistry
Nov 1990
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K903441 is an FDA 510(k) clearance for the MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS, a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on November 6, 1990, 98 days after receiving the submission on July 31, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K903441 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1990
Decision Date November 06, 1990
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHX — Fluorometric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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