Cleared Traditional

ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

K952818 · Pyramid Biological Corp. · Microbiology
Nov 1995
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K952818 is an FDA 510(k) clearance for the ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII, a Antigens, Iha, Toxoplasma Gondii (Class II — Special Controls, product code GMM), submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on November 20, 1995, 153 days after receiving the submission on June 20, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K952818 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1995
Decision Date November 20, 1995
Days to Decision 153 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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

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