NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM— 510(k) K790665

Name: FDA 510(k) clearance K790665
Creator: U.S. Food and Drug Administration
Published: 1979-05-15

Substantially Equivalent

Micromedic Systems

FDA 510(k) clearance K790665 for NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM, Substantially Equivalent on 1979-05-15. Applicant: Micromedic Systems. Device class: 2.

Clearance details

Applicant: Micromedic Systems
Product code: Product code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1979-04-06
Decision date: 1979-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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