FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MUELLER HINTON AGAR
K Number: K801901
·
Decision Aug 20, 1980
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
73
Applicant Total
7
Review Days
12
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Basic Information
- Device Name
- MUELLER HINTON AGAR
- K Number
- K801901
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Radiation Technology, Inc.
- Date Received
- August 8, 1980
- Decision Date
- August 20, 1980
- 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.
MUELLER HINTON AGAR
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MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
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MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
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MUELLER HINTON AGAR WITH 2% NACI
FDA 510(k)
FDA Class 2
·Microbiology
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
FDA 510(k)
FDA Class 2
·Microbiology
MUELLER HINTON AGAR W/OXACILLIN
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Radiation Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910648 | THERAPY CHAIR SYSTEM | Jul 22, 1991 | Substantially Equivalent |
| K802892 | CULTURE MEDIA FOR IN VITRO DIAG. USE | Dec 11, 1980 | Substantially Equivalent |
| K801943 | BRAIN HEART INFUSION MICROBIOLOGICAL | Sep 9, 1980 | Substantially Equivalent |
| K801817 | MICROBIOLOGY CULTURE MEDIA, C.L.E.D. | Aug 27, 1980 | Substantially Equivalent |
| K801772 | MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG | Aug 20, 1980 | Substantially Equivalent |
| K801847 | TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA | Aug 13, 1980 | Substantially Equivalent |