DIGOXIN COATED TUBE RIA— 510(k) K922353

Substantially Equivalent

Monobind

FDA 510(k) clearance K922353 for DIGOXIN COATED TUBE RIA, Substantially Equivalent on 1992-08-24. Applicant: Monobind. Device class: 2.

Clearance details

Applicant: Monobind
Product code: Code LCS
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1992-05-19
Decision date: 1992-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

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Recent devices under product code LCS

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K874748 — IMMPULSE DIGOXIN ASSAY REAGENTS1988-02-19
K864802 — DART DIGOXIN ASSAY1987-02-12

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Data sourced from openFDA. This site is unofficial and independent of the FDA.