I-DHEA-SULFATE RIA KIT 125— 510(k) K821145

Name: FDA 510(k) clearance K821145
Creator: U.S. Food and Drug Administration
Published: 1982-05-14

Substantially Equivalent

Nuclear Medical Systems, Inc.

FDA 510(k) clearance K821145 for I-DHEA-SULFATE RIA KIT 125, Substantially Equivalent on 1982-05-14. Applicant: Nuclear Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Nuclear Medical Systems, Inc.
Product code: Code JKC
Device class: Class 1
Regulation: 21 CFR 862.1245
Advisory panel: Clinical Chemistry
Date received: 1982-04-21
Decision date: 1982-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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