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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

IMMUNETICS C6 LYME ELISA KIT

Manufacturer

IMMUNETICS, INC.

Date Cleared

2001-05-10

(156 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K062473,K183446

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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