FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATIFY JCV DXSELECT
K Number: K120986
·
Decision Aug 16, 2012
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
14
Review Days
136
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Basic Information
- Device Name
- STRATIFY JCV DXSELECT
- K Number
- K120986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3336
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Focus Diagnostics, Inc.
- Date Received
- April 2, 2012
- Decision Date
- August 16, 2012
- Product Code
- OYP
- 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 |
|---|---|---|---|
| OYP | Anti-Jcv Antibody Detection Assay | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OYP), ordered by most recent decision date.
View allOther Clearances by Focus Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K073382 | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | Jul 28, 2008 | Substantially Equivalent |