FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FILMARRAY RP PANEL
K Number: K120267
·
Decision May 15, 2012
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
78
Applicant Total
8
Review Days
106
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Basic Information
- Device Name
- FILMARRAY RP PANEL
- K Number
- K120267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Idaho Technology, Inc.
- Date Received
- January 30, 2012
- Decision Date
- May 15, 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 Idaho Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K103207 | JBAIDS Q FEVER DETECTION KIT | May 20, 2011 | Substantially Equivalent |
| K110764 | FILMARRAY RP PANEL | Apr 27, 2011 | Substantially Equivalent |
| K103175 | FILMARRAY RESPIRATORY PANEL (RP) | Feb 17, 2011 | Substantially Equivalent |
| K072631 | JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 | Dec 20, 2007 | Substantially Equivalent |
| K072547 | JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 | Dec 19, 2007 | Substantially Equivalent |
| K071188 | MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM | May 21, 2007 | Substantially Equivalent |
| K051713 | JBAIDS ANTHRAC DETECTION SYSTEM | Nov 18, 2005 | Substantially Equivalent |