STRATUS ESTRADIOL FLUOREMETRIC ENZYME— 510(k) K910249

Name: FDA 510(k) clearance K910249
Creator: U.S. Food and Drug Administration
Published: 1991-02-13

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K910249 for STRATUS ESTRADIOL FLUOREMETRIC ENZYME, Substantially Equivalent on 1991-02-13. Applicant: Baxter Healthcare Corp. Device class: 1.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code CHP
Device class: Class 1
Regulation: 21 CFR 862.1260
Advisory panel: Clinical Chemistry
Date received: 1991-01-22
Decision date: 1991-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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