CMV Brite Antigenemia Test Kit

FDA 510(k) K951550 · Biotest Diagnostics Corp.

Substantially Equivalent

510(k) numberK951550

Submission

Device name
CMV Brite Antigenemia Test Kit
Applicant
Biotest Diagnostics Corp.
Denville, NJ, US
Received
April 4, 1995
Decision date
January 30, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3175
Specialty
Microbiology

Other 510(k)s with product code LIN

510(k)DeviceApplicantDecision
K081164D3 Dfa Cytomegalovirus Immediate Early Antigen Identification KitLIN · Traditional Diagnostic Hybrids, Inc.06/13/2008SE
K983762Nuclisens CMV PP67LIN · Traditional Organon Teknika Corp.09/15/1999SE
K991650CMV Brite Turbo KitLIN · Special Biotest Diagnostics Corp.07/12/1999SE
K951821Cytomegalovirus Direct Immunofluorescence AssayLIN · Traditional Light Diagnostics06/07/1996SE
K934798Pathodx CytomegalovirusLIN · Traditional Diagnostic Products Corp.03/25/1994SE
K921616Cmv-Vue(Tm) CMV Antigen Detection KitLIN · Traditional Incstar Corp.08/11/1992SN
K912592Cmv-Ea Mab TestLIN · Traditional Gull Laboratories, Inc.12/04/1991SE
K905257Opus CMV Test SystemLIN · Traditional Pb Diagnostic Systems, Inc.04/17/1991SE
K904036Bartels Cytomegalovirus Immed. Early AntigenLIN · Traditional Baxter Healthcare Corp10/16/1990SE
K894002Cytomegalovirus Fluorescent Monoclonal AntibodyLIN · Traditional Baxter Healthcare Corp08/10/1989SE

More from Baxter Healthcare Corp

510(k)DeviceDecision
K991650CMV Brite Turbo KitLIN · Special 07/12/1999SE
K983842Biotest Anti-Ebv Recombinant, Ea IgmLSE · Traditional 06/09/1999SE
K983841Biotest Anti-Ebv Recombinant, Ebna IggLSE · Traditional 06/09/1999SE
K983839Biotest Anti-Ebv RecombinantLSE · Traditional 06/09/1999SE

Questions and answers

When was CMV Brite Antigenemia Test Kit cleared by the FDA?

CMV Brite Antigenemia Test Kit (K951550) received a 510(k) decision of Substantially Equivalent on January 30, 1996, 301 days after the submission was received.

What is the product code of K951550?

The FDA product code is LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.