BICARBONATE TEST— 510(k) K810356

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K810356 for BICARBONATE TEST, Substantially Equivalent on 1981-02-23. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1981-02-10
Decision date: 1981-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.