FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CULTURE PLATES & TUBED MEDIA
K Number: K792481
·
Decision Dec 31, 1979
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
73
Applicant Total
8
Review Days
42
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Basic Information
- Device Name
- CULTURE PLATES & TUBED MEDIA
- K Number
- K792481
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Laboratory Products, Inc.
- Date Received
- November 19, 1979
- Decision Date
- December 31, 1979
- 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 Laboratory Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832588 | CIN AGAR | Sep 12, 1983 | Substantially Equivalent |
| K803051 | FLAME PHOTOMETRY REAGENTS | Jan 9, 1981 | Substantially Equivalent |
| K803013 | CHLORIDE/TCO2 ANALYZER REAGENTS | Jan 2, 1981 | Substantially Equivalent |
| K803050 | SPRAY, SYNTHETIC SMEAR | Dec 30, 1980 | Substantially Equivalent |
| K800180 | VARIOUS REAGENTS FOR BLOOD CELL ANALYZER | Mar 19, 1980 | Substantially Equivalent |
| K792482 | CHEMISTRY ANALYZER REAGENTS | Jan 11, 1980 | Substantially Equivalent |
| K792483 | STAINS, COUNTERSTAINS & GEN. PURPOSE | Dec 18, 1979 | Substantially Equivalent |