N-ACETYLPROCAINAMIDE ACA-ANALYTICAL
FDA 510(k) clearance K833378 · decided 1983-12-27
Clearance details
- K-number
- K833378
- Device name
- N-ACETYLPROCAINAMIDE ACA-ANALYTICAL
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-29
- Decision date
- 1983-12-27
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- LAN
- Device class
- 2
- Regulation number
- 862.3320
- 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.