RIA PHASE DIGOXIN— 510(k) K800205

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K800205 for RIA PHASE DIGOXIN, Substantially Equivalent on 1980-03-19. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code DPO
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1980-01-30
Decision date: 1980-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPO

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K833842 — RIA COAT DIGOXIN1984-01-17
K832163 — SOPHEIA DIGOXIN EIA KIT1983-08-12

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