FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MUELLER HINTON BROTH
K Number: K842854
·
Decision Aug 17, 1984
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
73
Applicant Total
7
Review Days
28
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Basic Information
- Device Name
- MUELLER HINTON BROTH
- K Number
- K842854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Anarobe Systems
- Date Received
- July 20, 1984
- Decision Date
- August 17, 1984
- Product Code
- JTZ
- 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 |
|---|---|---|---|
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JTZ), ordered by most recent decision date.
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MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
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MUELLER HINTON AGAR WITH 2% NACI
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CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
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MUELLER HINTON AGAR W/OXACILLIN
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Other Clearances by Anarobe Systems
| K Number | Device Name | ||
|---|---|---|---|
| K842850 | TRIPLE SUGAR IRON | Aug 17, 1984 | Substantially Equivalent |
| K842851 | ORNITHINE INDOLE MOTILITY | Aug 7, 1984 | Substantially Equivalent |
| K842855 | CHRISTENSEN'S UREA AGAR | Aug 3, 1984 | Substantially Equivalent |
| K842849 | TRYPTICASE SOY BROTH | Aug 3, 1984 | Substantially Equivalent |
| K842853 | LYSINE IRON AGAR | Aug 3, 1984 | Substantially Equivalent |
| K842852 | BRAIN HEART INFUSION BROTH | Aug 3, 1984 | Substantially Equivalent |