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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

MODIFICATION OF ACL ADVANCE

Manufacturer

INSTRUMENTATION LABORATORY CO.

Date Cleared

2000-08-30

(26 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K021023,K023839,K024082,K030287,K030964,K030965,K031122,K031829,K033414,K034007,K041905,K043459,K050661

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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