Light Diagnostics Simulfluor Hsv/Vzv Immunoflourescence Assay, Model 3295
FDA 510(k) K990141 · Light Diagnostics
510(k) numberK990141
Submission
- Device name
- Light Diagnostics Simulfluor Hsv/Vzv Immunoflourescence Assay, Model 3295
- Applicant
- Light Diagnostics
Temecula, CA, US - Received
- January 19, 1999
- Decision date
- October 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GQW – Antigen, Cf, (Including Cf Control), Varicella-Zoster
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3900
- Specialty
- Microbiology
Other 510(k)s with product code GQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070206 | Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000GQW · Traditional | Diagnostic Hybrids, Inc. | 08/30/2007SE |
| K964872 | VZV Antigen Control SlidesGQW · Traditional | Viral Antigens, Inc. | 03/18/1997SE |
| K942743 | Viro Varicella-Zoster Virus Identification ReagentGQW · Traditional | Viro Research, Inc. | 12/15/1994SE |
| K912239 | Vzvscan(Tm) Latex Aggutination TestGQW · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/11/1991SE |
| K903882 | Varicella-Zoster Virus Antibody Test Kit-Latex AggGQW · Traditional | Viral Antigens, Inc. | 12/04/1990SE |
| K894622 | Varicella Zoster VirusGQW · Traditional | Bion Ent., Ltd. | 10/24/1989SE |
| K843676 | Varicella/Zoster VirusGQW · Traditional | Institute Virion , Ltd. | 09/26/1985SE |
| K841434 | Varicella-Zoster(Igg) Ifa TestGQW · Traditional | Zeus Scientific, Inc. | 04/19/1985SE |
| K802938 | Varicella-Zoster Antigens & ControlsGQW · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
More from Orion Diagnostica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991880 | Light Diagnostics Simulfluor HSV 1/2 Immunofluorecence AssayGQN · Traditional | 11/09/1999SE |
| K972975 | Light Diagnostics Rabies Dfa ReagentGOI · Traditional | 12/22/1998SE |
| K974302 | Light Diagnostics Simulfluor Flu A/Flu BGNW · Traditional | 04/08/1998SE |
| K951821 | Cytomegalovirus Direct Immunofluorescence AssayLIN · Traditional | 06/07/1996SE |
| K951799 | Varicella-Zoster Virus Direct Immunofluorescence AssayGQX · Traditional | 03/20/1996SE |
| K940034 | Poliovirus 2 Monoclonal AntibodyGOE · Traditional | 09/12/1995SE |
| K940026 | Poliovirus Blend Monoclonal AntibodiesGOE · Traditional | 09/12/1995SE |
| K940017 | Poliovirus 3 Monoclonal AntibodyGOE · Traditional | 09/12/1995SE |
| K940363 | Enterovirus 70 Monclonal AntibodyGOE · Traditional | 09/08/1995SE |
| K940018 | Poliovirus 1 Monoclonal AntibodyGOE · Traditional | 09/08/1995SE |
Questions and answers
When was Light Diagnostics Simulfluor Hsv/Vzv Immunoflourescence Assay, Model 3295 cleared by the FDA?
Light Diagnostics Simulfluor Hsv/Vzv Immunoflourescence Assay, Model 3295 (K990141) received a 510(k) decision of Substantially Equivalent on October 19, 1999, 273 days after the submission was received.
What is the product code of K990141?
The FDA product code is GQW – Antigen, Cf, (Including Cf Control), Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.