510(k) K852931
- Device
- HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
- Applicant
- MICROBIX BIOSYSTEMS, INC.
- 510(k) number
- K852931
- Product code
- GQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-12
- Date received
- 1985-07-09
- 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
- WILLIAM J GASTLE
- Address
- 341 Bering Ave. Toronto, Ontario M9a 4x3 Canada CA
FDA Registration Numbers#
- 2032682
- 2029372
- 1419968
- 1181055
- 3004973408
- 1318354
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GQO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883281 | VIRGO HSV-2 IGG ELISA | Electro-Nucleonics, Inc. | 1989-03-10 |
| K883282 | VIRGO HSV-1 IGG ELISA | Electro-Nucleonics, Inc. | 1989-03-10 |
| K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | Bion Ent., Ltd. | 1988-06-07 |
| K875366 | THE DDI SERODOT HERPES IGG TEST KIT | Disease Detection International, Inc. | 1988-05-23 |
| K871426 | VIROGEN HSV ANTIBODY TEST | Armkel, LLC | 1987-10-15 |
| K861120 | THE GOLDEN QUAD TEST (HSV) | Microbiological Research Corp. | 1987-02-02 |
| K854712 | VISIBLE-HERPES TM TEST SYSTEM | Isolab, Inc. | 1986-05-20 |
| K852781 | HSV2 - IGG ELISA-KIT | Clinical Sciences, Inc. | 1986-01-21 |
| K852782 | HSVI - IGG ELISA-KIT | Clinical Sciences, Inc. | 1986-01-21 |
| K842531 | AMIZYME-HSV TYPES 1 & 2 TEST KITS | Amico Lab, Inc. | 1985-12-06 |
| K842663 | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 | Amico Lab, Inc. | 1985-12-06 |
| K841245 | ENZYGNOST ANTIHERPES SIMPLEX VIRUS | Behring Diagnostics, Inc. | 1985-11-05 |
| K852928 | VIROGEN HERPES SLIDE TEST | Armkel, LLC | 1985-10-17 |
| K842887 | HERPES VIRUS AGGLUTINATION TEST | Scientific Research | 1985-02-26 |
| K791058 | ANTIBODY TO HERPESVIRUS HOMINIS | Electro-Nucleonics Laboratories, Inc. | 1979-09-07 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases