FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROFAST+ ASSAY
K Number: K101855
·
Decision Jul 23, 2010
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
9
Applicant Total
10
Review Days
22
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Basic Information
- Device Name
- PROFAST+ ASSAY
- K Number
- K101855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3332
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gen-Probe Prodesse, Inc.
- Date Received
- July 1, 2010
- Decision Date
- July 23, 2010
- Product Code
- OQW
- 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 |
|---|---|---|---|
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 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 |
| K132129 | PRODESSE PROFLU+ ASSAY | Aug 9, 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 |