DUPONT ACALACTIC ACID (LA) TEST— 510(k) K802064
Substantially EquivalentE.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearance K802064 for DUPONT ACALACTIC ACID (LA) TEST, Substantially Equivalent on 1980-09-26. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.
Clearance details
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Product code
- Code KHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1450
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KHP
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