FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BioCode® Respiratory Pathogen Panel (RPP)
K Number: K254139
·
Decision May 1, 2026
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
78
Applicant Total
5
Review Days
130
Basic Information
- Device Name
- BioCode® Respiratory Pathogen Panel (RPP)
- K Number
- K254139
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied BioCode, Inc.
- Date Received
- December 22, 2025
- Decision Date
- May 1, 2026
- 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 Applied BioCode, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | Jan 10, 2025 | Substantially Equivalent |
| K192485 | BioCode Respiratory Pathogen Panel (RPP) | Dec 23, 2019 | Substantially Equivalent |
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | Jun 5, 2019 | Substantially Equivalent |
| K180041 | BioCode Gastrointestinal Pathogen Panel (GPP) | Sep 28, 2018 | Substantially Equivalent |