ATROXIN— 510(k) K780355

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K780355 for ATROXIN, Substantially Equivalent on 1978-04-18. Applicant: Sigma Chemical Co.. Device class: 2.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code JCO
Device class: Class 2
Regulation: 21 CFR 864.8100
Advisory panel: Hematology
Date received: 1978-03-03
Decision date: 1978-04-18
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.