FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRODESSE PROFLU+ ASSAY
K Number: K132129
·
Decision Aug 9, 2013
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
78
Applicant Total
10
Review Days
30
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Basic Information
- Device Name
- PRODESSE PROFLU+ ASSAY
- K Number
- K132129
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gen-Probe Prodesse, Inc.
- Date Received
- July 10, 2013
- Decision Date
- August 9, 2013
- 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 Gen-Probe Prodesse, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K132238 | PROPARAFLU+ ASSAY | Aug 26, 2013 | Substantially Equivalent |
| K132237 | PRODESSE PROFAST+ ASSAY | Aug 26, 2013 | Substantially Equivalent |
| K132159 | PROADENO+ ASSAY | Aug 14, 2013 | Substantially Equivalent |
| K132200 | PRO HMPV+ ASSAY | Aug 14, 2013 | Substantially Equivalent |
| K123274 | PROGASTRO SSCS ASSAY | Jan 16, 2013 | Substantially Equivalent |
| K123838 | PRO HMPV+ ASSAY | Jan 16, 2013 | Substantially Equivalent |
| K110968 | PROFLU+ ASSAY | Jun 27, 2011 | Substantially Equivalent |
| K102952 | PRODESSE PROADENO | Dec 3, 2010 | Substantially Equivalent |
| K101855 | PROFAST+ ASSAY | Jul 23, 2010 | Substantially Equivalent |