FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 1 results

510(k) Data Aggregation

K Number

Device Name

MTS Doxycycline 0.016 - 256 µg/mL

Manufacturer

Liofilchem s. r. l.

Date Cleared

2019-05-29

(51 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

MTS Doxycycline 0.016 - 256 µg/mL

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA clearance letter for a device named "MTS Doxycycline 0.016 - 256 µg/mL" and mainly discusses regulatory matters and compliance.

Ask a Question

Ask a specific question about this device

Page 1 of 1