FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUID THIOGLYCOLLATE BROTH
K Number: K821598
·
Decision Jul 6, 1982
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
51
Applicant Total
114
Review Days
47
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Basic Information
- Device Name
- FLUID THIOGLYCOLLATE BROTH
- K Number
- K821598
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2350
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Hardy Media
- Date Received
- May 20, 1982
- Decision Date
- July 6, 1982
- Product Code
- JSC
- 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 |
|---|---|---|---|
| JSC | Culture Media, General Nutrient Broth | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSC), ordered by most recent decision date.
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BRAIN HEART INFUSION BROTH
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SABOURAUD BHI AGAR
FDA 510(k)
FDA Class 1
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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 |