ABNORMAL HEMATOLOGY CONTROL UNASSAYED— 510(k) K781573

Name: FDA 510(k) clearance K781573
Creator: U.S. Food and Drug Administration
Published: 1978-10-17

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K781573 for ABNORMAL HEMATOLOGY CONTROL UNASSAYED, Substantially Equivalent on 1978-10-17. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1978-09-14
Decision date: 1978-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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