FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BioSign Flu A+B
K Number: K182157
·
Decision Sep 18, 2018
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
71
Applicant Total
72
Review Days
40
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BioSign Flu A+B
- K Number
- K182157
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3328
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Princeton BioMeditech Corp.
- Date Received
- August 9, 2018
- Decision Date
- September 18, 2018
- Product Code
- PSZ
- 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 |
|---|---|---|---|
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PSZ), ordered by most recent decision date.
Nano-Check Influenza A+B Test
FDA 510(k)
FDA Class 2
·Microbiology
Innovita Flu A/B Antigen Rapid Test
FDA 510(k)
FDA Class 2
·Microbiology
Acucy® Influenza A&B Test with the Acucy® 2 System
FDA 510(k)
FDA Class 2
·Microbiology
BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit
FDA 510(k)
FDA Class 2
·Microbiology
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
FDA 510(k)
FDA Class 2
·Microbiology
Osom Ultra Plus Flu A&B Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Princeton BioMeditech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K251538 | Status COVID-19/Flu A&B | Nov 14, 2025 | 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 |