ANTIMICROBIAL REMOVAL DEVICE (ARD)
FDA 510(k) clearance K822344 · decided 1982-08-25
Clearance details
- K-number
- K822344
- Device name
- ANTIMICROBIAL REMOVAL DEVICE (ARD)
- Applicant
- Marion Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-05
- Decision date
- 1982-08-25
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- LJF
- Device class
- 1
- Regulation number
- 866.2560
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BACT/ALERT CSR (K003104) | Organon Teknika Corp. | 2000-10-20 |
| ARTIMICROBIAL REMOVAL DEVICE (K830372) | Marion Laboratories, Inc. | 1983-04-08 |
| BACTEC 170 TRYPTIC SOY BROTH W/RESINS (K830363) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-03-24 |
Recalls involving this device
No recalls on record reference this clearance.