FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
K Number: K945911
·
Decision Apr 4, 1995
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
73
Applicant Total
13
Review Days
123
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Basic Information
- Device Name
- CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
- K Number
- K945911
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bioclinical Systems, Inc.
- Date Received
- December 2, 1994
- Decision Date
- April 4, 1995
- 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 AGAR WITH 5% SHEEP BLOOD
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MUELLER HINTON AGAR WITH 2% NACI
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MUELLER HINTON AGAR W/OXACILLIN
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MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
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Other Clearances by Bioclinical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950196 | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA | Jun 30, 1995 | Substantially Equivalent |
| K933122 | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR | Feb 9, 1994 | Substantially Equivalent |
| K933121 | MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR | Feb 3, 1994 | Substantially Equivalent |
| K873086 | ROUND 1 | Aug 24, 1987 | Substantially Equivalent |
| K860334 | VISI-CHECK HLH TEST MONOCLONAL | Apr 21, 1986 | Substantially Equivalent |
| K860333 | MICRO-ELISA HLH TEST KIT MONOCLONAL | Apr 21, 1986 | Substantially Equivalent |
| K855227 | MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL | Apr 11, 1986 | Substantially Equivalent |
| K854059 | MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO | Jan 13, 1986 | Substantially Equivalent |
| K854379 | MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT | Jan 7, 1986 | Substantially Equivalent |
| K850257 | BCS GLUCOSE COLORIMETRIC TEST | Mar 5, 1985 | Substantially Equivalent |