Cleared Traditional

IMMUNOENZYME TEST SYS-DETECT-IGM ANTI

K832900 · Bionetic Laboratory Products · Immunology
Nov 1983
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K832900 is an FDA 510(k) clearance for the IMMUNOENZYME TEST SYS-DETECT-IGM ANTI, a Antigens, If, Toxoplasma Gondii (Class II — Special Controls, product code GLZ), submitted by Bionetic Laboratory Products (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983, 77 days after receiving the submission on August 29, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K832900 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1983
Decision Date November 14, 1983
Days to Decision 77 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code GLZ — Antigens, If, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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