FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BACT/ALERT 120
K Number: K934593
·
Decision Feb 9, 1994
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
66
Applicant Total
130
Review Days
138
Basic Information
- Device Name
- BACT/ALERT 120
- K Number
- K934593
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORGANON TEKNIKA CORP.
- Date Received
- September 24, 1993
- Decision Date
- February 9, 1994
- Product Code
- MDB
- 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 |
|---|---|---|---|
| MDB | System, Blood Culturing | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MDB), ordered by most recent decision date.
BD BACTEC Plus Aerobic/F Culture Vials
FDA 510(k)
FDA Class 1
·Microbiology
BD BACTEC Myco/F Lytic Culture Vials
FDA 510(k)
FDA Class 1
·Microbiology
BACT/ALERT MP Reagent System
FDA 510(k)
FDA Class 1
·Microbiology
BacT/ALERT FA Plus; BacT/ALERT PF Plus
FDA 510(k)
FDA Class 1
·Microbiology
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
FDA 510(k)
FDA Class 1
·Microbiology
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by ORGANON TEKNIKA CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K003104 | BACT/ALERT CSR | Oct 20, 2000 | Substantially Equivalent |
| K000492 | MDA D-DIMER | Jun 7, 2000 | Substantially Equivalent |
| K000378 | BACT/ALERT MB CULTURE BOTTLE | Mar 2, 2000 | Substantially Equivalent |
| K994343 | BACT/ALERT SV | Feb 10, 2000 | Substantially Equivalent |
| K993423 | BACT/ALERT SA | Dec 15, 1999 | Substantially Equivalent |
| K993421 | BACT/ALERT SN | Dec 14, 1999 | Substantially Equivalent |
| K993576 | BACT/ALERT MP PROCESS BOTTLE | Dec 14, 1999 | Substantially Equivalent |
| K992432 | BACT/ALERT FN | Sep 24, 1999 | Substantially Equivalent |
| K983762 | NUCLISENS CMV PP67 | Sep 15, 1999 | Substantially Equivalent |
| K992401 | BACT/ALERT PF | Sep 3, 1999 | Substantially Equivalent |