FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLUMBIA AGAR BASE
K Number: K811641
·
Decision Jul 2, 1981
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
208
Applicant Total
114
Review Days
23
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Basic Information
- Device Name
- COLUMBIA AGAR BASE
- K Number
- K811641
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hardy Media
- Date Received
- June 9, 1981
- Decision Date
- July 2, 1981
- Product Code
- JSG
- 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 |
|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-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 |