FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT
K Number: K874544
·
Decision Aug 12, 1988
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
4
Review Days
283
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Basic Information
- Device Name
- SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT
- K Number
- K874544
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.7675
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Molecular Biosystems, Inc.
- Date Received
- November 3, 1987
- Decision Date
- August 12, 1988
- Product Code
- LGO
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| LGO | Test, Leukocyte Typing | FDA class 1 | Hematology |
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