HSV2 - Igg Elisa-Kit
FDA 510(k) K852781 · Clinical Sciences, Inc.
510(k) numberK852781
Submission
- Device name
- HSV2 - Igg Elisa-Kit
- Applicant
- Clinical Sciences, Inc.
Whippany, NJ, US - Received
- July 1, 1985
- Decision date
- January 21, 1986
- 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 |
| K842663 | Anti-Herpes Simplex Virus Type 1 or 2GQO · Traditional | Amico Lab, Inc. | 12/06/1985SE |
| K842531 | Amizyme-Hsv Types 1 & 2 Test KitsGQO · Traditional | Amico Lab, Inc. | 12/06/1985SE |
More from Amico Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K900688 | Varicella Zoster Igg Clin-Elisa Test KitLFY · Traditional | 05/15/1990SE |
| K883871 | Epstein-Barr Viral Capsid Antigen Igm #5590LSE · Traditional | 07/14/1989SE |
| K883870 | Epstein-Barr Viral Capsid Antigen Igg #4590LSE · Traditional | 07/14/1989SE |
| K891990 | Rubeola Igg Clin-Elisa Test System, Cat. #4600LJB · Traditional | 06/15/1989SE |
| K883601 | Epstein-Barr Virus (EBNA-1) Igm Cata. #5550LLM · Traditional | 05/11/1989SE |
| K883600 | Epstein-Barr Virus (EBNA-1) Igg Cata. #4550LLM · Traditional | 05/11/1989SE |
| K874594 | Toxoplasma Igm Clin-Elisa(Tm) Cat # 5560LGD · Traditional | 03/07/1988SE |
| K872942 | Igm CMV Clin-Elisa(Tm) Test System Number: 5530LKQ · Traditional | 01/11/1988SE |
| K860145 | Rubella Elisa Test System Catalog Number: 4540LFX · Traditional | 07/14/1986SE |
| K860773 | Toxoplasma Igg Clin-Elisa Test Kit Cat. No. 4560LGD · Traditional | 05/23/1986SE |
Questions and answers
When was HSV2 - Igg Elisa-Kit cleared by the FDA?
HSV2 - Igg Elisa-Kit (K852781) received a 510(k) decision of Substantially Equivalent on January 21, 1986, 204 days after the submission was received.
What is the product code of K852781?
The FDA product code is GQO – Antisera, Cf, Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.