FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BACTEC FUNGAL MEDIUM
K Number: K954923
·
Decision Nov 21, 1996
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
10
Applicant Total
13
Review Days
392
Basic Information
- Device Name
- BACTEC FUNGAL MEDIUM
- K Number
- K954923
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
- Date Received
- October 26, 1995
- Decision Date
- November 21, 1996
- Product Code
- JTA
- 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 |
|---|---|---|---|
| JTA | Monitor, Microbial Growth | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JTA), ordered by most recent decision date.
BACTEC NR-860
FDA 510(k)
FDA Class 1
·Microbiology
BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
BACTEC NR-730 BACTERIAL DETECTION SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
RADIOMETRIC BLOOD CULTURE VIALS, AEROBE
FDA 510(k)
FDA Class 1
·Microbiology
BECTEC NR-660 BACTERIAL DETECT SYS
FDA 510(k)
FDA Class 1
·Microbiology
BAC-T-SCREEN
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
| K Number | Device Name | ||
|---|---|---|---|
| K954932 | BBL MGIT PRODUCTS | Aug 21, 1996 | Substantially Equivalent |
| K962210 | BACTEC 9050 SYSTEM | Aug 8, 1996 | Substantially Equivalent |
| K946268 | BACTEC(R) 9000TB SYSTEM | May 21, 1996 | Substantially Equivalent |
| K960827 | QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) | May 17, 1996 | Substantially Equivalent |
| K954921 | BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS | Feb 16, 1996 | Substantially Equivalent |
| K954927 | BACTEC PEDS PLUS/F CULTURE VIALS | Feb 16, 1996 | Substantially Equivalent |
| K954925 | BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS | Feb 16, 1996 | Substantially Equivalent |
| K954930 | BACTEC CULTURE VIALS, LYTIC, ANAEROBIC | Feb 16, 1996 | Substantially Equivalent |
| K954924 | BACTEC PEDS PLUS CLUTURE VIALS | Feb 8, 1996 | Substantially Equivalent |
| K955504 | QBC ACCUREAD SYSTEM | Feb 5, 1996 | Substantially Equivalent |