Virgo(R) Vzv-Igg Elisa
FDA 510(k) K883427 · Electro-Nucleonics, Inc.
510(k) numberK883427
Submission
- Device name
- Virgo(R) Vzv-Igg Elisa
- Applicant
- Electro-Nucleonics, Inc.
Columbia, MD, US - Received
- August 15, 1988
- Decision date
- March 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQX – Antiserum, Cf, Varicella-Zoster
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3900
- Specialty
- Microbiology
Other 510(k)s with product code GQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951799 | Varicella-Zoster Virus Direct Immunofluorescence AssayGQX · Traditional | Light Diagnostics | 03/20/1996SE |
| K911301 | VZV Igm TestGQX · Traditional | Gull Laboratories, Inc. | 07/17/1991SE |
| K875358 | VZV TestGQX · Traditional | Gull Laboratories, Inc. | 03/31/1988SE |
| K863317 | Enzygnost Anti-Vzv Igg TestGQX · Traditional | Behring Diagnostics, Inc. | 04/22/1987SE |
| K853540 | Fiax Test Kit for Varicella Antibody SerologyGQX · Traditional | Idt, A Division of Whittaker M.A. Bioproducts | 02/04/1986SE |
| K852930 | Varicella-Zoster-Comple Fix Antigen and Neg ControGQX · Traditional | Microbix Biosystems, Inc. | 11/12/1985SE |
| K842096 | GLB Varicella-Zoster Virus FluorescentGQX · Traditional | Great Lakes Bioscience | 01/07/1985SE |
| K841526 | Ortho Varicella-Zoster Virus Ident.GQX · Traditional | Ortho Diagnostic Systems, Inc. | 06/25/1984SE |
| K770810 | Varicella-Zoster Fa Labeled PreserumGQX · Traditional | Flow Laboratories, Inc. | 05/20/1977SE |
| K770806 | Varicella-Zoster Fa Labelled (8-321 RF)GQX · Traditional | Flow Laboratories, Inc. | 05/20/1977SE |
More from Flow Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893718 | Deltatest (R) Lipase IICET · Traditional | 09/28/1989SE |
| K883670 | Serological Test Kit for Igg Anti. Epstein-Barr ViGNP · Traditional | 04/28/1989SE |
| K883282 | Virgo HSV-1 Igg ElisaGQO · Traditional | 03/10/1989SE |
| K883281 | Virgo HSV-2 Igg ElisaGQO · Traditional | 03/10/1989SE |
| K883102 | Virgo (R) Cmv-Igg ElisaGQI · Traditional | 02/08/1989SE |
| K884784 | Virgo(R) Microwell Alt AssayCKD · Traditional | 12/29/1988SE |
| K883206 | Lactate Dehydrogenase LDHCFJ · Traditional | 09/09/1988SE |
| K883205 | Altlts Alanine Amino Transferase AltCKA · Traditional | 09/09/1988SE |
Questions and answers
When was Virgo(R) Vzv-Igg Elisa cleared by the FDA?
Virgo(R) Vzv-Igg Elisa (K883427) received a 510(k) decision of Substantially Equivalent on March 10, 1989, 207 days after the submission was received.
What is the product code of K883427?
The FDA product code is GQX – Antiserum, Cf, Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.