FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CULTURIA EMB/COLUMBIA CNA W/5% SHEEP
K Number: K792284
·
Decision Dec 19, 1979
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
43
Applicant Total
6
Review Days
36
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Basic Information
- Device Name
- CULTURIA EMB/COLUMBIA CNA W/5% SHEEP
- K Number
- K792284
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Clinical Convenience Products, Inc.
- Date Received
- November 13, 1979
- Decision Date
- December 19, 1979
- Product Code
- JXA
- 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 |
|---|---|---|---|
| JXA | Kit, Screening, Urine | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXA), ordered by most recent decision date.
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
FDA 510(k)
FDA Class 1
·Microbiology
URISCREEN
FDA 510(k)
FDA Class 1
·Microbiology
URINE SCREENING DEVICE
FDA 510(k)
FDA Class 1
·Microbiology
TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
FDA 510(k)
FDA Class 1
·Microbiology
MULTIPLE (IZON DBS & URINE COLLECTION KIT)
FDA 510(k)
FDA Class 1
·Microbiology
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Clinical Convenience Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934759 | CULTURIA MACCONKEY-MUG | Sep 9, 1994 | Substantially Equivalent |
| K870502 | CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS | Feb 26, 1987 | 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 |