FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
K Number: K071510
·
Decision Sep 24, 2007
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
19
Applicant Total
14
Review Days
112
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Basic Information
- Device Name
- HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
- K Number
- K071510
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Focus Diagnostics, Inc.
- Date Received
- June 4, 2007
- Decision Date
- September 24, 2007
- Product Code
- MXJ
- 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 |
|---|---|---|---|
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | FDA class 2 | Microbiology |
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|---|---|---|---|
| K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack | Sep 21, 2015 | Substantially Equivalent |
| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack | Mar 18, 2015 | Substantially Equivalent |
| K120986 | STRATIFY JCV DXSELECT | Aug 16, 2012 | Substantially Equivalent |
| K120413 | SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK | Jul 13, 2012 | Substantially Equivalent |
| K113433 | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT | Apr 4, 2012 | Substantially Equivalent |
| DEN120008 | STRATIFY JCV(TM) ANTIBODY | Jan 20, 2012 | Unknown |
| K102170 | SIMPLEXA FLU A/B & RSV | Nov 24, 2010 | Substantially Equivalent |
| K102314 | 3M INTEGRATED CYCLER (110V) & (220V) | Oct 29, 2010 | Substantially Equivalent |
| K100148 | SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 | May 24, 2010 | Substantially Equivalent |
| K073381 | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M | Aug 4, 2008 | Substantially Equivalent |