Ortho Varicella-Zoster Virus Ident.
FDA 510(k) K841526 · Ortho Diagnostic Systems, Inc.
510(k) numberK841526
Submission
- Device name
- Ortho Varicella-Zoster Virus Ident.
- Applicant
- Ortho Diagnostic Systems, Inc.
Carpinteria, CA, US - Received
- April 12, 1984
- Decision date
- June 25, 1984
- 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 |
| K842096 | GLB Varicella-Zoster Virus FluorescentGQX · Traditional | Great Lakes Bioscience | 01/07/1985SE |
| 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 |
|---|---|---|
| K951459 | Ortho-Mune Okt 4A (CD4) - Monoclonal Antibody (Murine) Fitc ConjugateGKZ · Traditional | 07/14/1997SE |
| K951632 | Ortho-Mune Ok-Combo Control IGG2A-FITC/IGG2A-PE Monoclonal Antibody (Murine)GKZ · Traditional | 03/06/1997SE |
| K964754 | Ortho-Mune Okb (CD19)- Monoclonal Antibody (Murine) Phycoerythrine ConjugateGKZ · Traditional | 01/22/1997SE |
| K963902 | Quantitative Fibrinogen AssayGIS · Traditional | 11/29/1996SE |
| K951100 | Ortho-Mune Ok-Combo CD3-FITC/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950625 | Ortho-Mune Ok-Combo CD40FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950568 | Ortho-Mune Ok-Combo CD3-FITC/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950482 | Ortho-Mune Ok-Comvo CD3-FITC/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/10/1996SE |
| K935720 | Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry SystemGKZ · Traditional | 05/09/1996SE |
| K954570 | Ortho Immunocount Flow Cytometry SystemGKZ · Traditional | 04/30/1996SE |
Questions and answers
When was Ortho Varicella-Zoster Virus Ident. cleared by the FDA?
Ortho Varicella-Zoster Virus Ident. (K841526) received a 510(k) decision of Substantially Equivalent on June 25, 1984, 74 days after the submission was received.
What is the product code of K841526?
The FDA product code is GQX – Antiserum, Cf, Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.