STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY— 510(k) K923286

Name: FDA 510(k) clearance K923286
Creator: U.S. Food and Drug Administration
Published: 1992-09-17

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K923286 for STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY, Substantially Equivalent on 1992-09-17. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 1992-07-06
Decision date: 1992-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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