FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CULTURE MEDIUM FOR ANTIMICROBIAL SUS
K Number: K832243
·
Decision Sep 29, 1983
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
73
Applicant Total
11
Review Days
83
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Basic Information
- Device Name
- CULTURE MEDIUM FOR ANTIMICROBIAL SUS
- K Number
- K832243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Carroll Biological Corp.
- Date Received
- July 8, 1983
- Decision Date
- September 29, 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
Other Clearances by Carroll Biological Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K832617 | XYLOSE LYSINE DEOXYCHOLATE | Sep 12, 1983 | Substantially Equivalent |
| K832615 | SF BROTH | Sep 12, 1983 | Substantially Equivalent |
| K832612 | CHOCOLATE AGAR & THAYER MARTIN AGAR | Sep 12, 1983 | Substantially Equivalent |
| K832619 | THIOGLYCOLLATE MEDIUM | Sep 12, 1983 | Substantially Equivalent |
| K832614 | SELENITE BROTH | Sep 12, 1983 | Substantially Equivalent |
| K832620 | TRYPTIC SOY BROTH MEDIA | Sep 12, 1983 | Substantially Equivalent |
| K832611 | TRYPTIC SOY AGAR | Sep 12, 1983 | Substantially Equivalent |
| K832613 | MANNITOL SALT AGAR | Sep 12, 1983 | Substantially Equivalent |
| K832618 | BLUE AGAR | Sep 12, 1983 | Substantially Equivalent |
| K832616 | MACCONKEY AGAR MEDIA | Sep 12, 1983 | Substantially Equivalent |