FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
K Number: K850291
·
Decision May 10, 1985
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
73
Applicant Total
137
Review Days
106
Basic Information
- Device Name
- MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
- K Number
- K850291
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- REMEL CO.
- Date Received
- January 24, 1985
- Decision Date
- May 10, 1985
- 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 |
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|---|---|---|---|
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| K941444 | BHI AGAR WITH VANCOMYCIN | Sep 19, 1994 | Substantially Equivalent |