510(k) K802938
- Device
- VARICELLA-ZOSTER ANTIGENS & CONTROLS
- Applicant
- ORION DIAGNOSTICA, INC.
- 510(k) number
- K802938
- Product code
- GQW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-12-31
- Date received
- 1980-11-19
- Regulation
- 866.3900
- Classification name
- Antigen, Cf, (including Cf Control), Varicella-zoster
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1419968
- 3016467093
- 3004973408
- 1528450
- 2242436
- 2029372
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GQW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K070206 | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 | Diagnostic Hybrids, Inc. | 2007-08-30 |
| K990141 | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 | Light Diagnostics | 1999-10-19 |
| K964872 | VZV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | 1997-03-18 |
| K942743 | VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT | Viro Research, Inc. | 1994-12-15 |
| K912239 | VZVSCAN(TM) LATEX AGGUTINATION TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-06-11 |
| K903882 | VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG | Viral Antigens, Inc. | 1990-12-04 |
| K894622 | VARICELLA ZOSTER VIRUS | Bion Ent., Ltd. | 1989-10-24 |
| K843676 | VARICELLA/ZOSTER VIRUS | Institute Virion , Ltd. | 1985-09-26 |
| K841434 | VARICELLA-ZOSTER(IGG) IFA TEST | Zeus Scientific, Inc. | 1985-04-19 |
Legacy Summary#
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FDA Review#
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