Cleared Traditional

CMV BIO-BEAD SCREEN KIT

K791612 · Litton Bionetics · Microbiology
Nov 1979
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K791612 is an FDA 510(k) clearance for the CMV BIO-BEAD SCREEN KIT, a Antigen, Cf (including Cf Control), Cytomegalovirus (Class II — Special Controls, product code GQH), submitted by Litton Bionetics (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979, 84 days after receiving the submission on August 21, 1979. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K791612 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1979
Decision Date November 13, 1979
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQH — Antigen, Cf (including Cf Control), Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

Similar Devices — GQH Antigen, Cf (including Cf Control), Cytomegalovirus

All 18
BARTELS CINAKIT CMV ANTIGENEMIA
K982311 · Intracel Corp. · Dec 1998
CMV ANTIGEN CONTROL SLIDES
K964875 · Viral Antigens, Inc. · Mar 1997
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
K935809 · Light Diagnostics · May 1994
INDIRECT FLUORESCENT ASSAY FOR (HCMV)
K882835 · Stellar Bio Systems, Inc. · Dec 1988
FITC MURINE MONOCLONAL ANTI-CMV IGG
K882024 · Whittaker Bioproducts, Inc. · Aug 1988
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
K881932 · Ortho Diagnostic Systems, Inc. · Aug 1988