AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM— 510(k) K791325

Name: FDA 510(k) clearance K791325
Creator: U.S. Food and Drug Administration
Published: 1979-08-16

Substantially Equivalent

Micromedic Systems

FDA 510(k) clearance K791325 for AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM, Substantially Equivalent on 1979-08-16. Applicant: Micromedic Systems. Device class: 2.

Clearance details

Applicant: Micromedic Systems
Product code: Code DPO
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1979-07-12
Decision date: 1979-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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