FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CETRIMIDE SELECTIVE AGAR
K Number: K870640
·
Decision Apr 14, 1987
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
114
Review Days
60
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Basic Information
- Device Name
- CETRIMIDE SELECTIVE AGAR
- K Number
- K870640
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hardy Media
- Date Received
- February 13, 1987
- Decision Date
- April 14, 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 Hardy Media
| K Number | Device Name | ||
|---|---|---|---|
| K880131 | LOWENSTEIN-JENSEN, GRUFT | Mar 31, 1988 | Substantially Equivalent |
| K880134 | MIDDLEBROOK 7H11 AGAR | Mar 31, 1988 | Substantially Equivalent |
| K880133 | MIL MEDIUM | Mar 31, 1988 | Substantially Equivalent |
| K880123 | LOWENSTEIN-JENSEN SLANT | Mar 31, 1988 | Substantially Equivalent |
| K880126 | LAURYL TRYPTOSE BROTH | Mar 31, 1988 | Substantially Equivalent |
| K880124 | LOWENSTEIN-JENSEN, W/NACL | Mar 31, 1988 | Substantially Equivalent |
| K880125 | LOWENSTEIN-JENSEN, SELECTIVE | Mar 31, 1988 | Substantially Equivalent |
| K880121 | MOELLERS DECARBOXYLASE, BASE | Mar 31, 1988 | Substantially Equivalent |
| K880116 | MRVP BROTH | Mar 31, 1988 | Substantially Equivalent |
| K880119 | MOELLERS DECARBOXYLASE, ONITHINE | Mar 31, 1988 | Substantially Equivalent |