GLB Varicella-Zoster Virus Fluorescent
FDA 510(k) K842096 · Great Lakes Bioscience
510(k) numberK842096
Submission
- Device name
- GLB Varicella-Zoster Virus Fluorescent
- Applicant
- Great Lakes Bioscience
St. Joseph, MI, US - Received
- May 25, 1984
- Decision date
- January 7, 1985
- 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 |
| K883427 | Virgo(R) Vzv-Igg ElisaGQX · Traditional | Electro-Nucleonics, Inc. | 03/10/1989SE |
| 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 |
| 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 |
Questions and answers
When was GLB Varicella-Zoster Virus Fluorescent cleared by the FDA?
GLB Varicella-Zoster Virus Fluorescent (K842096) received a 510(k) decision of Substantially Equivalent on January 7, 1985, 227 days after the submission was received.
What is the product code of K842096?
The FDA product code is GQX – Antiserum, Cf, Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.