PRECINORM HB— 510(k) K852136

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K852136 for PRECINORM HB, Substantially Equivalent on 1985-07-05. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code GGM
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1985-05-16
Decision date: 1985-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.