FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROGASTRO SSCS ASSAY
K Number: K123274
·
Decision Jan 16, 2013
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
37
Applicant Total
10
Review Days
89
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Basic Information
- Device Name
- PROGASTRO SSCS ASSAY
- K Number
- K123274
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3990
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gen-Probe Prodesse, Inc.
- Date Received
- October 19, 2012
- Decision Date
- January 16, 2013
- Product Code
- PCH
- 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 |
|---|---|---|---|
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based 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 |
| K132129 | PRODESSE PROFLU+ ASSAY | Aug 9, 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 |