ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE— 510(k) K861361

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K861361 for ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE, Substantially Equivalent on 1986-06-27. Applicant: Serono Diagnostics, Inc..

Clearance details

Applicant
Serono Diagnostics, Inc.
Product code
Code CHP
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Norwell, MA, US
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