ACETAMINOPHEN-SL ASSAY
FDA 510(k) clearance K042330 · decided 2005-01-07
Clearance details
- K-number
- K042330
- Device name
- ACETAMINOPHEN-SL ASSAY
- Applicant
- Diagnostic Chemicals , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-27
- Decision date
- 2005-01-07
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- LDP
- Device class
- 2
- Regulation number
- 862.3030
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Charlottetown, Prince Edward, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended recall (Z-1902-2012) | Sekisui Diagnostics Llc | 2012-06-27 |
| MULTIGENT Acetaminophen, List Number 2K99-20 recall (Z-1233-2007) | Abbott Laboratories Inc. | 2007-09-18 |