FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST
K Number: K882199
·
Decision Oct 6, 1988
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
1
Review Days
134
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Basic Information
- Device Name
- CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST
- K Number
- K882199
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Auspharm Intl. , Ltd.
- Date Received
- May 25, 1988
- Decision Date
- October 6, 1988
- 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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