ANTITHROMBIN III ASSAY— 510(k) K781480
Substantially EquivalentDade, Baxter Travenol Diagnostics, Inc.
FDA 510(k) clearance K781480 for ANTITHROMBIN III ASSAY, Substantially Equivalent on 1978-11-08. Applicant: Dade, Baxter Travenol Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- Product code
- Code JBQ
- Device class
- Class 2
- Regulation
- 21 CFR 864.7060
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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