ELUAID— 510(k) K812002

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K812002 for ELUAID, Substantially Equivalent on 1981-10-28. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant
Ortho Diagnostic Systems, Inc.
Product code
Code GGK
Device class
Class 1
Regulation
21 CFR 864.8540
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carpinteria, CA, US
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