STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY— 510(k) K933635

Name: FDA 510(k) clearance K933635
Creator: U.S. Food and Drug Administration
Published: 1993-10-08

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K933635 for STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY, Substantially Equivalent on 1993-10-08. 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: 1993-07-27
Decision date: 1993-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

Download summary PDF View on FDA.gov ↗

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