MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST— 510(k) K901858
Substantially EquivalentE.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearance K901858 for MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST, Substantially Equivalent on 1990-06-12. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.
Clearance details
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Product code
- Code CET
- Device class
- Class 1
- Regulation
- 21 CFR 862.1465
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
Recent devices under product code CET
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