LOW LEVEL HUMAN ALBUMIN TEST KITS— 510(k) K761225

Name: FDA 510(k) clearance K761225
Creator: U.S. Food and Drug Administration
Published: 1977-04-07

Substantially Equivalent

Intl. Diagnostic Technology

FDA 510(k) clearance K761225 for LOW LEVEL HUMAN ALBUMIN TEST KITS, Substantially Equivalent on 1977-04-07. Applicant: Intl. Diagnostic Technology. Device class: 2.

Clearance details

Applicant: Intl. Diagnostic Technology
Product code: Code DCF
Device class: Class 2
Regulation: 21 CFR 866.5040
Advisory panel: Immunology
Date received: 1976-12-08
Decision date: 1977-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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