IRON SYSTEM PACK REAGENTS— 510(k) K892838

Name: FDA 510(k) clearance K892838
Creator: U.S. Food and Drug Administration
Published: 1989-06-16

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K892838 for IRON SYSTEM PACK REAGENTS, Substantially Equivalent on 1989-06-16. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1989-04-18
Decision date: 1989-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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