Light Diagnostics Simulfluor HSV 1/2 Immunofluorecence Assay
FDA 510(k) K991880 · Light Diagnostics
510(k) numberK991880
Submission
- Device name
- Light Diagnostics Simulfluor HSV 1/2 Immunofluorecence Assay
- Applicant
- Light Diagnostics
Temecula, CA, US - Received
- June 2, 1999
- Decision date
- November 9, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GQN – Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
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| K971662 | Elvis HSV Id/Typing Test SystemGQN · Traditional | Diagnostic Hybrids, Inc. | 11/18/1997SE |
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| K960578 | Elvis HSV GoldGQN · Traditional | Diagnostic Hybrids, Inc. | 09/05/1996SE |
| K941924 | Elvis HSVGQN · Traditional | Diagnostic Hybrids, Inc. | 05/01/1995SE |
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| K884761 | Modified Cell-Matics Herpes Simplex Virus Detect.GQN · Traditional | Difco Laboratories, Inc. | 12/05/1988SE |
| K883684 | Herpes Virus Control SlidesGQN · Traditional | Val Tech Diagnostics, Inc. | 09/28/1988SE |
More from Val Tech Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990141 | Light Diagnostics Simulfluor Hsv/Vzv Immunoflourescence Assay, Model 3295GQW · Traditional | 10/19/1999SE |
| 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 1/2 Immunofluorecence Assay cleared by the FDA?
Light Diagnostics Simulfluor HSV 1/2 Immunofluorecence Assay (K991880) received a 510(k) decision of Substantially Equivalent on November 9, 1999, 160 days after the submission was received.
What is the product code of K991880?
The FDA product code is GQN – Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.