510(k) K003104
- Device
- BACT/ALERT CSR
- Applicant
- ORGANON TEKNIKA CORP.
- 510(k) number
- K003104
- Product code
- LJF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-10-20
- Date received
- 2000-08-29
- Regulation
- 866.2560
- Classification name
- Device, Antimicrobial Drug Removal
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- REBECCA A RIVAS
- Address
- 100 Akzo Ave. Durham NC US 27712 27712
Source Documents#
Other 510(k) Records For Product Code LJF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K830372 | ARTIMICROBIAL REMOVAL DEVICE | Marion Laboratories, Inc. | 1983-04-08 |
| K830363 | BACTEC 170 TRYPTIC SOY BROTH W/RESINS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-03-24 |
| K822344 | ANTIMICROBIAL REMOVAL DEVICE (ARD) | Marion Laboratories, Inc. | 1982-08-25 |
Legacy Summary#
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FDA Review#
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