CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN— 510(k) K900448
Substantially EquivalentE.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearance K900448 for CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN, Substantially Equivalent on 1990-02-16. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.
Clearance details
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Product code
- Code EAM
- Device class
- Class 1
- Regulation
- 21 CFR 892.1960
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
Recent devices under product code EAM
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