125I ESTRADIOL DIRECT RADIOIMMUNOASSAY— 510(k) K853208
Substantially EquivalentTravenol Laboratories, S.A.
FDA 510(k) clearance K853208 for 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY, Substantially Equivalent on 1985-08-19. Applicant: Travenol Laboratories, S.A.. Device class: 1.
Clearance details
- Applicant
- Travenol Laboratories, S.A.
- Product code
- Code CHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1260
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
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