Cleared Traditional

CMV IGG HUMAN SERUM CONTROLS

K951800 · Pyramid Biological Corp. · Microbiology
Nov 1995
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K951800 is an FDA 510(k) clearance for the CMV IGG HUMAN SERUM CONTROLS, 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, 212 days after receiving the submission on April 18, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K951800 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1995
Decision Date November 16, 1995
Days to Decision 212 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

Similar Devices — GQI Antiserum, Cf, Cytomegalovirus

All 17
ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
K952254 · Pyramid Biological Corp. · Nov 1995
CMV EARLY ANTIGEN TEST
K942171 · Neogenex · Jun 1994
VIRGO (R) CMV-IGG ELISA
K883102 · Electro-Nucleonics, Inc. · Feb 1989
DETECTADOT SYSTEM 2000 CMV IGG TEST
K875159 · Gull Laboratories, Inc. · May 1988
ENZYGNOST ANTI-CMV IGG TEST
K863488 · Behring Diagnostics, Inc. · Jul 1987
THE GOLDEN QUAD TEST (CMV)
K861123 · Microbiological Research Corp. · Feb 1987