ACETAMINOPHER ASSAY KIT
FDA 510(k) clearance K832045 · decided 1983-10-04
Clearance details
- K-number
- K832045
- Device name
- ACETAMINOPHER ASSAY KIT
- Applicant
- Quantimetrix Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-24
- Decision date
- 1983-10-04
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- LDP
- Device class
- 2
- Regulation number
- 862.3030
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.