FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HSV IDR
K Number: K854974
·
Decision Mar 7, 1986
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
33
Applicant Total
9
Review Days
85
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Basic Information
- Device Name
- HSV IDR
- K Number
- K854974
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Genus Diagnostics
- Date Received
- December 12, 1985
- Decision Date
- March 7, 1986
- Product Code
- GQN
- 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 |
|---|---|---|---|
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GQN), ordered by most recent decision date.
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
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DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
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LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
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FDA Class 2
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ELVIS HSV ID/TYPING TEST SYSTEM
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FDA Class 2
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HSV-2 ANTIGEN CONTROL SLIDES
FDA 510(k)
FDA Class 2
·Microbiology
HSV-1 ANTIGEN CONTROL SLIDES
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Genus Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K852206 | HEP-2 GENCELLS | Jun 4, 1985 | Substantially Equivalent |
| K852204 | MCCOY GENCELLS | Jun 4, 1985 | Substantially Equivalent |
| K852205 | RMK GENCELLS CULTURE SYSTEM | Jun 4, 1985 | Substantially Equivalent |
| K851927 | VERO GENCELLS | May 20, 1985 | Substantially Equivalent |
| K851928 | HEK GENCELLS | May 20, 1985 | Substantially Equivalent |
| K851561 | WI-38 GENCELLS | May 10, 1985 | Substantially Equivalent |
| K851562 | MRC-5 GENCELLS | May 10, 1985 | Substantially Equivalent |
| K851563 | RK GENCELLS | May 10, 1985 | Substantially Equivalent |