FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREPARED MACCONKEY AGAR
K Number: K833508
·
Decision Nov 7, 1983
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
3
Review Days
27
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Basic Information
- Device Name
- PREPARED MACCONKEY AGAR
- K Number
- K833508
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Lavco Laboratory, Inc.
- Date Received
- October 11, 1983
- Decision Date
- November 7, 1983
- Product Code
- JSI
- 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | FDA class 1 | Microbiology |
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