FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEISSERIASTAT
K Number: K860156
·
Decision Mar 11, 1986
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
1
Review Days
54
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Basic Information
- Device Name
- NEISSERIASTAT
- K Number
- K860156
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Richardson Scientific, Inc.
- Date Received
- January 16, 1986
- Decision Date
- March 11, 1986
- Product Code
- JTO
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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