FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS
K Number: K870502
·
Decision Feb 26, 1987
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
6
Review Days
22
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Basic Information
- Device Name
- CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS
- K Number
- K870502
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Clinical Convenience Products, Inc.
- Date Received
- February 4, 1987
- Decision Date
- February 26, 1987
- 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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Other Clearances by Clinical Convenience Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934759 | CULTURIA MACCONKEY-MUG | Sep 9, 1994 | Substantially Equivalent |
| K864764 | CULTURIA MACCONKEY-MUG/CLED SYSTEMS | Dec 29, 1986 | Substantially Equivalent |
| K800215 | CULTURIA MACCONKEY/CLED #DM87 | Feb 13, 1980 | Substantially Equivalent |
| K792579 | CULTURIA MACCONKEY/COLUMBIA CNA | Jan 11, 1980 | Substantially Equivalent |
| K792284 | CULTURIA EMB/COLUMBIA CNA W/5% SHEEP | Dec 19, 1979 | Substantially Equivalent |