FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREPARED MUELLER HINTON MED/100 MM
K Number: K833506
·
Decision Dec 1, 1983
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
73
Applicant Total
3
Review Days
51
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PREPARED MUELLER HINTON MED/100 MM
- K Number
- K833506
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Lavco Laboratory, Inc.
- Date Received
- October 11, 1983
- Decision Date
- December 1, 1983
- 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
FDA 510(k)
FDA Class 2
·Microbiology
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
FDA 510(k)
FDA Class 2
·Microbiology
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
FDA 510(k)
FDA Class 2
·Microbiology
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