FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
K Number: K990141
·
Decision Oct 19, 1999
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
9
Applicant Total
19
Review Days
273
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Basic Information
- Device Name
- LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
- K Number
- K990141
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Light Diagnostics
- Date Received
- January 19, 1999
- Decision Date
- October 19, 1999
- Product Code
- GQW
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GQW), ordered by most recent decision date.
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
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VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG
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·Microbiology
VARICELLA ZOSTER VIRUS
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Light Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K991880 | LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY | Nov 9, 1999 | Substantially Equivalent |
| K972975 | LIGHT DIAGNOSTICS RABIES DFA REAGENT | Dec 22, 1998 | Substantially Equivalent |
| K974302 | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B | Apr 8, 1998 | Substantially Equivalent |
| K951821 | CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | Jun 7, 1996 | Substantially Equivalent |
| K951799 | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | Mar 20, 1996 | Substantially Equivalent |
| K940017 | POLIOVIRUS 3 MONOCLONAL ANTIBODY | Sep 12, 1995 | Substantially Equivalent |
| K940034 | POLIOVIRUS 2 MONOCLONAL ANTIBODY | Sep 12, 1995 | Substantially Equivalent |
| K940026 | POLIOVIRUS BLEND MONOCLONAL ANTIBODIES | Sep 12, 1995 | Substantially Equivalent |
| K936254 | COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY | Sep 8, 1995 | Substantially Equivalent |
| K936252 | COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY | Sep 8, 1995 | Substantially Equivalent |