FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
Vstrip H. pylori Antigen Rapid Test
K Number: K183573
·
Decision Mar 14, 2019
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
1
Review Days
83
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
- Vstrip H. pylori Antigen Rapid Test
- K Number
- K183573
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Panion & BF Biotech, Inc.
- Date Received
- December 21, 2018
- Decision Date
- March 14, 2019
- Product Code
- LYR
- 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 |
|---|---|---|---|
| LYR | Helicobacter Pylori | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYR), ordered by most recent decision date.
Hp Detect Stool Antigen ELISA
FDA 510(k)
FDA Class 1
·Microbiology
Premier HpSA Flex (619096)
FDA 510(k)
FDA Class 1
·Microbiology
Curian HpSA, Curian Analyzer
FDA 510(k)
FDA Class 1
·Microbiology
PREMIER Platinum HpSA PLUS
FDA 510(k)
FDA Class 1
·Microbiology
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
FDA 510(k)
FDA Class 1
·Microbiology
H. PYLORI CHEK
FDA 510(k)
FDA Class 1
·Microbiology