ORTHO LOW IONIC SOLUTION— 510(k) K781435

Name: FDA 510(k) clearance K781435
Creator: U.S. Food and Drug Administration
Published: 1978-09-14

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K781435 for ORTHO LOW IONIC SOLUTION, Substantially Equivalent on 1978-09-14. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code KSG
Device class: Class 2
Regulation: 21 CFR 864.9600
Advisory panel: Hematology
Date received: 1978-08-16
Decision date: 1978-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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