BI-LEVEL ASSAYED CARD. DRUG CONT., I,II— 510(k) K800357

Name: FDA 510(k) clearance K800357
Creator: U.S. Food and Drug Administration
Published: 1980-04-16

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K800357 for BI-LEVEL ASSAYED CARD. DRUG CONT., I,II, Substantially Equivalent on 1980-04-16. Applicant: Ortho Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code LAS
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1980-02-20
Decision date: 1980-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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