510(k) K883427
- Device
- VIRGO(R) VZV-IGG ELISA
- Applicant
- ELECTRO-NUCLEONICS, INC.
- 510(k) number
- K883427
- Product code
- GQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-03-10
- Date received
- 1988-08-15
- Regulation
- 866.3900
- Classification name
- Antiserum, Cf, Varicella-zoster
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN DARCY
- Address
- 8310 Guilford Rd. Columbia MD US 21046 21046
FDA Registration Numbers#
- 1524213
- 1318354
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GQX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951799 | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | 1996-03-20 |
| K911301 | VZV IGM TEST | Gull Laboratories, Inc. | 1991-07-17 |
| K875358 | VZV TEST | Gull Laboratories, Inc. | 1988-03-31 |
| K863317 | ENZYGNOST ANTI-VZV IGG TEST | Behring Diagnostics, Inc. | 1987-04-22 |
| K853540 | FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY | Idt, A Division of Whittaker M.A. Bioproducts | 1986-02-04 |
| K852930 | VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO | Microbix Biosystems, Inc. | 1985-11-12 |
| K842096 | GLB VARICELLA-ZOSTER VIRUS FLUORESCENT | Great Lakes Bioscience | 1985-01-07 |
| K841526 | ORTHO VARICELLA-ZOSTER VIRUS IDENT. | Ortho Diagnostic Systems, Inc. | 1984-06-25 |
| K770806 | VARICELLA-ZOSTER FA LABELLED (8-321 RF) | Flow Laboratories, Inc. | 1977-05-20 |
| K770810 | VARICELLA-ZOSTER FA LABELED PRESERUM | Flow Laboratories, Inc. | 1977-05-20 |
Legacy Summary#
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FDA Review#
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