BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE— 510(k) K914202

Name: FDA 510(k) clearance K914202
Creator: U.S. Food and Drug Administration
Published: 1991-10-11

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K914202 for BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE, Substantially Equivalent on 1991-10-11. Applicant: Baxter Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1991-09-19
Decision date: 1991-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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