FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SIM MEDIUM
K Number: K850551
·
Decision Mar 11, 1985
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
52
Applicant Total
114
Review Days
28
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Basic Information
- Device Name
- SIM MEDIUM
- K Number
- K850551
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hardy Media
- Date Received
- February 11, 1985
- Decision Date
- March 11, 1985
- Product Code
- JSE
- 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 |
|---|---|---|---|
| JSE | Culture Media, Multiple Biochemical Test | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSE), ordered by most recent decision date.
MLX MICROTITER PLATE LUMINOMETER
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X-ACT UREA/TDA
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X-ACT LDC/IND
FDA 510(k)
FDA Class 1
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MIL MEDIUM
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MRVP BROTH
FDA 510(k)
FDA Class 1
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KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
FDA 510(k)
FDA Class 1
·Microbiology
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 |