FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BACT/ALERT CSR
K Number: K003104
·
Decision Oct 20, 2000
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
130
Review Days
52
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Basic Information
- Device Name
- BACT/ALERT CSR
- K Number
- K003104
- 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
- August 29, 2000
- Decision Date
- October 20, 2000
- Product Code
- LJF
- 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 |
|---|---|---|---|
| LJF | Device, Antimicrobial Drug Removal | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJF), ordered by most recent decision date.
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BACTEC 170 TRYPTIC SOY BROTH W/RESINS
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FDA Class 1
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ANTIMICROBIAL REMOVAL DEVICE (ARD)
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Organon Teknika Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K992400 | BACTALERT FA | Sep 3, 1999 | Substantially Equivalent |