FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SIM MEDIUM
K Number: K834012
·
Decision Dec 22, 1983
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
52
Applicant Total
52
Review Days
31
Basic Information
- Device Name
- SIM MEDIUM
- K Number
- K834012
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- MICRO MEDIA LABORATORIES
- Date Received
- November 21, 1983
- Decision Date
- December 22, 1983
- Product Code
- JSE
- 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 |
|---|---|---|---|
| JSE | Culture Media, Multiple Biochemical Test | FDA class 1 | Microbiology |
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|---|---|---|---|
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| K851348 | COBA AGAR | Apr 19, 1985 | Substantially Equivalent |
| K850848 | BRAIN HEART INFUSION AGAR | Mar 20, 1985 | Substantially Equivalent |
| K850845 | 0.85% SALINE | Mar 20, 1985 | Substantially Equivalent |