FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAMPYLOCACTER SELECTIVE AGAR BLASER'S
K Number: K830076
·
Decision Feb 9, 1983
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
74
Review Days
29
Basic Information
- Device Name
- CAMPYLOCACTER SELECTIVE AGAR BLASER'S
- K Number
- K830076
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- BIO MERIEUX, INC.
- Date Received
- January 11, 1983
- Decision Date
- February 9, 1983
- Product Code
- JSJ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | FDA class 1 | Microbiology |
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Other Clearances by BIO MERIEUX, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K925863 | SPUNCRIT | Feb 5, 1993 | Substantially Equivalent |
| K872646 | VIRON(TM) | Sep 14, 1987 | Substantially Equivalent |
| K871098 | TRYPTIC SOY AGAR | Apr 3, 1987 | Substantially Equivalent |
| K871095 | CLED AGAR | Apr 3, 1987 | Substantially Equivalent |
| K871097 | CHOCOLATE MUELLER HINTON AGAR | Apr 3, 1987 | Substantially Equivalent |
| K871093 | CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR) | Apr 3, 1987 | Substantially Equivalent |
| K871094 | BRILLIANT GREEN AGAR | Apr 3, 1987 | Substantially Equivalent |
| K871091 | BACTEROIDES BILE ESCULIN AGAR | Apr 3, 1987 | Substantially Equivalent |
| K871092 | HORSE BLOOD AGAR, ENRICHED | Apr 3, 1987 | Substantially Equivalent |
| K871090 | ANAEROBIC PEA BLOOD AGAR | Apr 3, 1987 | Substantially Equivalent |