CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4— 510(k) K901475
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K901475 for CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4, Substantially Equivalent on 1990-06-20. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code CDX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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