ESTRIOL RADIOIMMUNOASSAY TEST KIT— 510(k) K810695
Substantially EquivalentSerono Laboratories, Inc.
FDA 510(k) clearance K810695 for ESTRIOL RADIOIMMUNOASSAY TEST KIT, Substantially Equivalent on 1981-03-31. Applicant: Serono Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Serono 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
- Mchenry, IL, US
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More clearances from Serono Laboratories, Inc.
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