Cleared Traditional

ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

K952254 · Pyramid Biological Corp. · Microbiology
Nov 1995
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K952254 is an FDA 510(k) clearance for the ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS, a Antiserum, Cf, Cytomegalovirus (Class II — Special Controls, product code GQI), submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on November 16, 1995, 185 days after receiving the submission on May 15, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K952254 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1995
Decision Date November 16, 1995
Days to Decision 185 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GQI — Antiserum, Cf, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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