RADIOASSY KIT, 3H-FOLATE— 510(k) K760262

Name: FDA 510(k) clearance K760262
Creator: U.S. Food and Drug Administration
Published: 1976-08-03

Substantially Equivalent

Diamond Shamrock Corp.

FDA 510(k) clearance K760262 for RADIOASSY KIT, 3H-FOLATE, Substantially Equivalent on 1976-08-03. Applicant: Diamond Shamrock Corp.. Device class: 2.

Clearance details

Applicant: Diamond Shamrock Corp.
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 1976-07-21
Decision date: 1976-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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