FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
K Number: K952220
·
Decision Sep 17, 1996
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
3
Review Days
495
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Basic Information
- Device Name
- MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
- K Number
- K952220
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Meretek Diagnostics, Inc.
- Date Received
- May 11, 1995
- Decision Date
- September 17, 1996
- 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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