ORTHO*T-4 RIA (PEG) KIT— 510(k) K781483

Name: FDA 510(k) clearance K781483
Creator: U.S. Food and Drug Administration
Published: 1978-09-27

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K781483 for ORTHO*T-4 RIA (PEG) KIT, Substantially Equivalent on 1978-09-27. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1978-08-28
Decision date: 1978-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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