FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUIDEL HELICOBACTER PYLORI TEST
K Number: K903099
·
Decision Apr 17, 1991
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
93
Review Days
278
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Basic Information
- Device Name
- QUIDEL HELICOBACTER PYLORI TEST
- K Number
- K903099
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Quidel Corp.
- Date Received
- July 13, 1990
- Decision Date
- April 17, 1991
- 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 |
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