Cleared Traditional

CMV BRITE ANTIGENEMIA TEST KIT

K951550 · Biotest Diagnostics Corp. · Microbiology
Jan 1996
Decision
301d
Days
Class 2
Risk

About This 510(k) Submission

K951550 is an FDA 510(k) clearance for the CMV BRITE ANTIGENEMIA TEST KIT, a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II — Special Controls, product code LIN), submitted by Biotest Diagnostics Corp. (Denville, US). The FDA issued a Cleared decision on January 30, 1996, 301 days after receiving the submission on April 4, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K951550 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1995
Decision Date January 30, 1996
Days to Decision 301 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIN — Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

Similar Devices — LIN Antisera, Conjugated Fluorescent, Cytomegalovirus

All 16
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
K081164 · Diagnostic Hybrids, Inc. · Jun 2008
NUCLISENS CMV PP67
K983762 · Organon Teknika Corp. · Sep 1999
CMV BRITE TURBO KIT
K991650 · Biotest Diagnostics Corp. · Jul 1999
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951821 · Light Diagnostics · Jun 1996
PATHODX CYTOMEGALOVIRUS
K934798 · Diagnostic Products Corp. · Mar 1994
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
K921616 · Incstar Corp. · Aug 1992