CALIBRATOR A— 510(k) K830137

Substantially Equivalent

Hi Chem, Inc.

FDA 510(k) clearance K830137 for CALIBRATOR A, Substantially Equivalent on 1983-02-07. Applicant: Hi Chem, Inc.. Device class: 2.

Clearance details

Applicant: Hi Chem, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1983-01-13
Decision date: 1983-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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