ESTRADIOL DIRECT RIA KIT— 510(k) K851540
Substantially EquivalentBiotecx Laboratories, Inc.
FDA 510(k) clearance K851540 for ESTRADIOL DIRECT RIA KIT, Substantially Equivalent on 1985-06-06. Applicant: Biotecx Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Biotecx Laboratories, 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
- Friendswood, TX, US
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