FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
K Number: K120413
·
Decision Jul 13, 2012
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
78
Applicant Total
14
Review Days
154
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Basic Information
- Device Name
- SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
- K Number
- K120413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Focus Diagnostics, Inc.
- Date Received
- February 10, 2012
- Decision Date
- July 13, 2012
- Product Code
- OCC
- 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 |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | FDA class 2 | Microbiology |
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Other Clearances by Focus Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |
| K073382 | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | Jul 28, 2008 | Substantially Equivalent |