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510(k) K880604

Device
COLORGENE HSV DNA HYBRIDIZATION TEST
Applicant
ENZO BIOCHEM, INC.
510(k) number
K880604
Product code
GQN  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-03
Date received
1988-02-12
Regulation
866.3305
Classification name
Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
J OLSIEWSKI
Address
325 Hudson St. New York NY US 10013 10013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GQN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070265DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000Diagnostic Hybrids, Inc.2007-10-24
K063798DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000Diagnostic Hybrids, Inc.2007-09-21
K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYLight Diagnostics1999-11-09
K971662ELVIS HSV ID/TYPING TEST SYSTEMDiagnostic Hybrids, Inc.1997-11-18
K971101HSV-2 ANTIGEN CONTROL SLIDESViral Antigens, Inc.1997-07-01
K964874HSV-1 ANTIGEN CONTROL SLIDESViral Antigens, Inc.1997-07-01
K960578ELVIS HSV GOLDDiagnostic Hybrids, Inc.1996-09-05
K941924ELVIS HSVDiagnostic Hybrids, Inc.1995-05-01
K911345HSV IN SITU DNA PROBE HYBRIDIZATION TEST KITDiagnostic Hybrids, Inc.1991-06-17
K884761MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.Difco Laboratories, Inc.1988-12-05
K883684HERPES VIRUS CONTROL SLIDESVal Tech Diagnostics, Inc.1988-09-28
K873529HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KITDiagnostic Hybrids, Inc.1988-08-25
K875311WELLCOZYME HSV WZO2Wellcome Diagnostics1988-08-03
K881180FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGGWhittaker Bioproducts, Inc.1988-05-13
K880996FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGGWhittaker Bioproducts, Inc.1988-05-13

Legacy Summary#

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FDA Review#

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