DU PONT PHENYTOIN ASSAY AND CALIBRATOR
FDA 510(k) clearance K863888 · decided 1986-11-05
Clearance details
- K-number
- K863888
- Device name
- DU PONT PHENYTOIN ASSAY AND CALIBRATOR
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-06
- Decision date
- 1986-11-05
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- DIR
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch E.I. Dupont DE Nemours & Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.