PROCEDURE #430 & REAGENTS FOR ACETAMIN
FDA 510(k) clearance K822313 · decided 1982-08-24
Clearance details
- K-number
- K822313
- Device name
- PROCEDURE #430 & REAGENTS FOR ACETAMIN
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-03
- Decision date
- 1982-08-24
- Days to decision
- 21 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.