ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK— 510(k) K852520
Substantially EquivalentE.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearance K852520 for ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK, Substantially Equivalent on 1985-10-04. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.
Clearance details
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Product code
- Code GHH
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
Recent devices under product code GHH
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