DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH— 510(k) K935528
Substantially EquivalentE.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearance K935528 for DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH, Substantially Equivalent on 1994-01-28. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.
Clearance details
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Product code
- Code DBF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
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