ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)— 510(k) K912318
Substantially EquivalentSerono-Baker Diagnostics, Inc.
FDA 510(k) clearance K912318 for ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE), Substantially Equivalent on 1991-07-25. Applicant: Serono-Baker Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Serono-Baker Diagnostics, 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
- Allentown, PA, US
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More clearances from Serono-Baker Diagnostics, Inc.
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