ASTRA— 510(k) K811381

Substantially Equivalent

Chem-Elec, Inc.

FDA 510(k) clearance K811381 for ASTRA, Substantially Equivalent on 1981-08-13. Applicant: Chem-Elec, Inc.. Device class: 2.

Clearance details

Applicant: Chem-Elec, Inc.
Product code: Code JFL
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1981-05-15
Decision date: 1981-08-13
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.