FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Status COVID-19/Flu A&B
K Number: K251538
·
Decision Nov 14, 2025
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
10
Applicant Total
72
Review Days
179
Basic Information
- Device Name
- Status COVID-19/Flu A&B
- K Number
- K251538
- Device Class
- FDA class 2
- Clearance Type
- Dual Track
- Regulation Number
- 866.3987
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Princeton BioMeditech Corp.
- Date Received
- May 19, 2025
- Decision Date
- November 14, 2025
- Product Code
- SCA
- 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 |
|---|---|---|---|
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | FDA class 2 | Microbiology |
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Other Clearances by Princeton BioMeditech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K182157 | BioSign Flu A+B | Sep 18, 2018 | Substantially Equivalent |
| K130650 | STATUS DS OXY | Feb 26, 2014 | Substantially Equivalent |
| K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | Dec 10, 2013 | Substantially Equivalent |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | Sep 9, 2013 | Substantially Equivalent |
| K083746 | BIOSIGN FLU A+B | Nov 10, 2010 | Substantially Equivalent |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Jul 1, 2010 | Substantially Equivalent |
| K100341 | SPERMCHECK FERTILITY | May 4, 2010 | Substantially Equivalent |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | Oct 6, 2008 | Substantially Equivalent |
| K073039 | SPERMCHECK VASECTOMY | Jan 24, 2008 | Substantially Equivalent |
| K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP | Nov 26, 2007 | Substantially Equivalent |