ClearanceBrief
Panels › Microbiology › Product code GQO · Class 2

Antisera, Cf, Herpesvirus Hominis 1,2

Regulation 866.3305

0510(k)s in 12 months (16 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in GQO

Company510(k)sRecalls
Amico Lab, Inc.20
Armkel, LLC20
Clinical Sciences, Inc.20
Electro-Nucleonics, Inc.20
Behring Diagnostics, Inc.10
Bion Ent., Ltd.10
Bion Enterprises Ltd01
Disease Detection International, Inc.10
Electro-Nucleonics Laboratories, Inc.10
Isolab, Inc.10
Decided510(k)Device and applicantCode
Mar 10, 1989K883282VIRGO HSV-1 IGG ELISA
Electro-Nucleonics, Inc.
GQO
Mar 10, 1989K883281VIRGO HSV-2 IGG ELISA
Electro-Nucleonics, Inc.
GQO
Jun 7, 1988K881261BION HSV1-G OR HSV2-G TEST SYSTEM
Bion Ent., Ltd.
GQO
May 23, 1988K875366THE DDI SERODOT HERPES IGG TEST KIT
Disease Detection International, Inc.
GQO
Oct 15, 1987K871426VIROGEN HSV ANTIBODY TEST
Armkel, LLC
GQO
Feb 2, 1987K861120THE GOLDEN QUAD TEST (HSV)
Microbiological Research Corp.
GQO
May 20, 1986K854712VISIBLE-HERPES TM TEST SYSTEM
Isolab, Inc.
GQO
Jan 21, 1986K852782HSVI - IGG ELISA-KIT
Clinical Sciences, Inc.
GQO
Jan 21, 1986K852781HSV2 - IGG ELISA-KIT
Clinical Sciences, Inc.
GQO
Dec 6, 1985K842663ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2
Amico Lab, Inc.
GQO
Dec 6, 1985K842531AMIZYME-HSV TYPES 1 & 2 TEST KITS
Amico Lab, Inc.
GQO
Nov 12, 1985K852931HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
Microbix Biosystems, Inc., CA
GQO
Nov 5, 1985K841245ENZYGNOST ANTIHERPES SIMPLEX VIRUS
Behring Diagnostics, Inc.
GQO
Oct 17, 1985K852928VIROGEN HERPES SLIDE TEST
Armkel, LLC
GQO
Feb 26, 1985K842887HERPES VIRUS AGGLUTINATION TEST
Scientific Research
GQO
Sep 7, 1979K791058ANTIBODY TO HERPESVIRUS HOMINIS
Electro-Nucleonics Laboratories, Inc.
GQO

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