FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

K964355

Device Name

ONTRAK TESTCUP 5 (MODIFICATION)

Manufacturer

ROCHE DIAGNOSTIC SYSTEMS, INC.

Date Cleared

1996-12-13

(42 days)

Product Code

LCM

Regulation Number

N/A

Intended Use

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

N/A

Summary

N/A