DATA-TOPE SYSTEM DIGOXIN RIA— 510(k) K760416
Substantially EquivalentDade, Baxter Travenol Diagnostics, Inc.
FDA 510(k) clearance K760416 for DATA-TOPE SYSTEM DIGOXIN RIA, Substantially Equivalent on 1976-08-23. Applicant: Dade, Baxter Travenol Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- Product code
- Code DOG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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