STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY— 510(k) K950570

Name: FDA 510(k) clearance K950570
Creator: U.S. Food and Drug Administration
Published: 1995-04-11

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K950570 for STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1995-04-11. Applicant: Baxter Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code JLS
Device class: Class 1
Regulation: 21 CFR 862.1620
Advisory panel: Clinical Chemistry
Date received: 1995-02-03
Decision date: 1995-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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