Herpes Hominus I-Comple Fix Antigen & Negative CLT
FDA 510(k) K852931 · Microbix Biosystems, Inc.
510(k) numberK852931
Submission
- Device name
- Herpes Hominus I-Comple Fix Antigen & Negative CLT
- Applicant
- Microbix Biosystems, Inc.
Canada, CA - Received
- July 9, 1985
- Decision date
- November 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQO – Antisera, Cf, Herpesvirus Hominis 1,2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code GQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883282 | Virgo HSV-1 Igg ElisaGQO · Traditional | Electro-Nucleonics, Inc. | 03/10/1989SE |
| K883281 | Virgo HSV-2 Igg ElisaGQO · Traditional | Electro-Nucleonics, Inc. | 03/10/1989SE |
| K881261 | Bion HSV1-G or HSV2-G Test SystemGQO · Traditional | Bion Ent., Ltd. | 06/07/1988SE |
| K875366 | The Ddi Serodot Herpes Igg Test KitGQO · Traditional | Disease Detection International, Inc. | 05/23/1988SE |
| K871426 | Virogen HSV Antibody TestGQO · Traditional | Armkel, LLC | 10/15/1987SE |
| K861120 | The Golden Quad Test (HSV)GQO · Traditional | Microbiological Research Corp. | 02/02/1987SE |
| K854712 | Visible-Herpes TM Test SystemGQO · Traditional | Isolab, Inc. | 05/20/1986SE |
| K852782 | Hsvi - Igg Elisa-KitGQO · Traditional | Clinical Sciences, Inc. | 01/21/1986SE |
| K852781 | HSV2 - Igg Elisa-KitGQO · Traditional | Clinical Sciences, Inc. | 01/21/1986SE |
| K842663 | Anti-Herpes Simplex Virus Type 1 or 2GQO · Traditional | Amico Lab, Inc. | 12/06/1985SE |
More from Amico Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K894262 | Rubella Antigen and Control AntigenGON · Traditional | 10/16/1989SE |
| K894261 | Toxoplasma Gondii-Cf Antigen and Control AntigenGMN · Traditional | 10/16/1989SE |
| K852932 | Measles-Complement Fix Antigen & Negative CLTGRF · Traditional | 11/12/1985SE |
| K852930 | Varicella-Zoster-Comple Fix Antigen and Neg ControGQX · Traditional | 11/12/1985SE |
| K852929 | Cmv-Complement Fixation Antigen and Negative ContrGQI · Traditional | 11/12/1985SE |
| K852933 | Mycoplasma SPP Serological ReagentsGSB · Traditional | 08/01/1985SE |
Questions and answers
When was Herpes Hominus I-Comple Fix Antigen & Negative CLT cleared by the FDA?
Herpes Hominus I-Comple Fix Antigen & Negative CLT (K852931) received a 510(k) decision of Substantially Equivalent on November 12, 1985, 126 days after the submission was received.
What is the product code of K852931?
The FDA product code is GQO – Antisera, Cf, Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.