FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HM-CAP EIA TEST (MODIFICATION)
K Number: K955085
·
Decision Feb 9, 1996
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
15
Review Days
106
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Basic Information
- Device Name
- HM-CAP EIA TEST (MODIFICATION)
- K Number
- K955085
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Schiff & Co.
- Date Received
- October 26, 1995
- Decision Date
- February 9, 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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