FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAS FLUALERT A & B, SAS INFLUENZA A TEST
K Number: K132352
·
Decision Aug 22, 2013
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
17
Applicant Total
2
Review Days
24
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
- SAS FLUALERT A & B, SAS INFLUENZA A TEST
- K Number
- K132352
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 866.3330
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sa Scientific , Ltd.
- Date Received
- July 29, 2013
- Decision Date
- August 22, 2013
- Product Code
- GNX
- 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 |
|---|---|---|---|
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GNX), ordered by most recent decision date.
ALERE BINAXNOW INFLUENZA A & B CARD
FDA 510(k)
FDA Class 1
·Microbiology
REMEL XPECT FLU A&B
FDA 510(k)
FDA Class 1
·Microbiology
SOFIA INFLUENZA A+B FIA
FDA 510(k)
FDA Class 1
·Microbiology
QUICK VUE INFLUENZA
FDA 510(k)
FDA Class 1
·Microbiology
QUICKVUE INFLUENZA A+B
FDA 510(k)
FDA Class 1
·Microbiology
OSOM INFLUENZA A&B TEST MODEL 190
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Sa Scientific , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | Jun 28, 2007 | Substantially Equivalent |