FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CYTOCLONE A & B EIA
K Number: K911958
·
Decision Jul 30, 1991
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
41
Applicant Total
3
Review Days
88
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Basic Information
- Device Name
- CYTOCLONE A & B EIA
- K Number
- K911958
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cambridge Biotech Corp.
- Date Received
- May 3, 1991
- Decision Date
- July 30, 1991
- Product Code
- LLH
- 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 |
|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | FDA class 1 | Microbiology |
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