PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS— 510(k) K853866
Substantially EquivalentPantex, Div. Bio-Analysis, Inc.
FDA 510(k) clearance K853866 for PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS, Substantially Equivalent on 1985-10-15. Applicant: Pantex, Div. Bio-Analysis, Inc.. Device class: 1.
Clearance details
- Applicant
- Pantex, Div. Bio-Analysis, Inc.
- 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
- Santa Monica, CA, US
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More clearances from Pantex, Div. Bio-Analysis, Inc.
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