DIG RADIOIMMUNOASSAY TEST SYSTEM— 510(k) K852343

Name: FDA 510(k) clearance K852343
Creator: U.S. Food and Drug Administration
Published: 1985-07-09

Substantially Equivalent

M Nobird, Inc.

FDA 510(k) clearance K852343 for DIG RADIOIMMUNOASSAY TEST SYSTEM, Substantially Equivalent on 1985-07-09. Applicant: M Nobird, Inc.. Device class: 2.

Clearance details

Applicant: M Nobird, Inc.
Product code: Code DNL
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1985-06-03
Decision date: 1985-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

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K781834 — TEST SET, 125 I-DIGOXIN1979-01-03

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