ACA FIBRINOGEN CALIBRATOR— 510(k) K812628
Substantially EquivalentE.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearance K812628 for ACA FIBRINOGEN CALIBRATOR, Substantially Equivalent on 1981-11-24. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.
Clearance details
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Product code
- Code GFX
- Device class
- Class 2
- Regulation
- 21 CFR 864.7340
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GFX
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