Enzygnost Anti-Vzv Igg Test
FDA 510(k) K863317 · Behring Diagnostics, Inc.
510(k) numberK863317
Submission
- Device name
- Enzygnost Anti-Vzv Igg Test
- Applicant
- Behring Diagnostics, Inc.
La Jolla, CA, US - Received
- August 26, 1986
- Decision date
- April 22, 1987
- 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 |
| 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 |
|---|---|---|
| K973832 | Opus HLH ControlsJJX · Traditional | 10/27/1997SE |
| K972929 | N Antiserum to Human AlbuminDCF · Traditional | 10/20/1997SE |
| K972840 | N Antiserum to Human TransferrinDDG · Traditional | 10/17/1997SE |
| K973202 | Modification of Opus Ferritin Test SystemDBF · Traditional | 09/12/1997SE |
| K972316 | Opus D-DimerGHH · Traditional | 09/09/1997SE |
| K972116 | Von Willebrand ReagentGGP · Traditional | 07/25/1997SE |
| K972011 | Opus EthanolDIC · Traditional | 07/22/1997SE |
| K971600 | Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)DKB · Traditional | 06/25/1997SE |
| K971596 | Emit II Opiates 300/2000 AssayDJG · Traditional | 06/25/1997SE |
| K964595 | Opus Psa Test SystemLTJ · Traditional | 06/24/1997SE |
Questions and answers
When was Enzygnost Anti-Vzv Igg Test cleared by the FDA?
Enzygnost Anti-Vzv Igg Test (K863317) received a 510(k) decision of Substantially Equivalent on April 22, 1987, 239 days after the submission was received.
What is the product code of K863317?
The FDA product code is GQX – Antiserum, Cf, Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.