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510(k) K875366

Device
THE DDI SERODOT HERPES IGG TEST KIT
Applicant
DISEASE DETECTION INTERNATIONAL, INC.
510(k) number
K875366
Product code
GQO  
Decision
Substantially Equivalent (SESE)
Decision date
1988-05-23
Date received
1987-12-31
Regulation
866.3305
Classification name
Antisera, Cf, Herpesvirus Hominis 1,2
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
EL-BADRY, PHD
Address
17935 Sky Park Cir., Suite D Irvine CA US 92714 92714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GQO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883281VIRGO HSV-2 IGG ELISAElectro-Nucleonics, Inc.1989-03-10
K883282VIRGO HSV-1 IGG ELISAElectro-Nucleonics, Inc.1989-03-10
K881261BION HSV1-G OR HSV2-G TEST SYSTEMBion Ent., Ltd.1988-06-07
K871426VIROGEN HSV ANTIBODY TESTArmkel, LLC1987-10-15
K861120THE GOLDEN QUAD TEST (HSV)Microbiological Research Corp.1987-02-02
K854712VISIBLE-HERPES TM TEST SYSTEMIsolab, Inc.1986-05-20
K852781HSV2 - IGG ELISA-KITClinical Sciences, Inc.1986-01-21
K852782HSVI - IGG ELISA-KITClinical Sciences, Inc.1986-01-21
K842531AMIZYME-HSV TYPES 1 & 2 TEST KITSAmico Lab, Inc.1985-12-06
K842663ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2Amico Lab, Inc.1985-12-06
K852931HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLTMicrobix Biosystems, Inc.1985-11-12
K841245ENZYGNOST ANTIHERPES SIMPLEX VIRUSBehring Diagnostics, Inc.1985-11-05
K852928VIROGEN HERPES SLIDE TESTArmkel, LLC1985-10-17
K842887HERPES VIRUS AGGLUTINATION TESTScientific Research1985-02-26
K791058ANTIBODY TO HERPESVIRUS HOMINISElectro-Nucleonics Laboratories, Inc.1979-09-07

Legacy Summary#

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FDA Review#

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