DADE(R) TUMOR MARKER CONTROL— 510(k) K924919
Substantially EquivalentBaxter Diagnostics, Inc.
FDA 510(k) clearance K924919 for DADE(R) TUMOR MARKER CONTROL, Substantially Equivalent on 1993-08-05. Applicant: Baxter Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Baxter Diagnostics, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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