FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
K Number: K063798
·
Decision Sep 21, 2007
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
33
Applicant Total
37
Review Days
273
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Basic Information
- Device Name
- DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
- K Number
- K063798
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostic Hybrids, Inc.
- Date Received
- December 22, 2006
- Decision Date
- September 21, 2007
- 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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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
ELVIS HSV GOLD
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Diagnostic Hybrids, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN140004 | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | May 13, 2014 | Unknown |
| K092229 | THYRETAIN TM TSI REPORTER BIOASSAY | May 18, 2010 | Substantially Equivalent |
| K093415 | D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT | Dec 23, 2009 | Substantially Equivalent |
| K093233 | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT | Dec 4, 2009 | Substantially Equivalent |
| K092882 | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT | Oct 21, 2009 | Substantially Equivalent |
| K091171 | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT | Sep 11, 2009 | Substantially Equivalent |
| K092300 | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | Aug 28, 2009 | Substantially Equivalent |
| K091753 | ELVIS HSV ID AND D3 TYPING TEST SYSTEM | Aug 28, 2009 | Substantially Equivalent |
| K083391 | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY | May 21, 2009 | Substantially Equivalent |
| K090073 | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT | Mar 6, 2009 | Substantially Equivalent |