FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAMBACH AGAR
K Number: K912924
·
Decision Feb 28, 1992
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
48
Applicant Total
4
Review Days
240
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Basic Information
- Device Name
- RAMBACH AGAR
- K Number
- K912924
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rantran, Inc.
- Date Received
- July 3, 1991
- Decision Date
- February 28, 1992
- Product Code
- JSS
- 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 |
|---|---|---|---|
| JSS | Kit, Identification, Enterobacteriaceae | FDA class 1 | Microbiology |
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