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Found 1 results

510(k) Data Aggregation

K Number

Device Name

Intera Refill Kit

Manufacturer

Intera Oncology, Inc.

Date Cleared

2022-03-16

(98 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

Intera Refill Kit

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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