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

FDA 510(k) Search

K Number

K011465

Device Name

SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO

Manufacturer

BECKMAN COULTER, INC.

Date Cleared

2001-06-08

(25 days)

Product Code

LDP CDQ CDT CEK CEM CFJ CFR CGA CGS CGX CGZ CHH CHI CHW CIG CIT CJE CJW CJY CKA CZP DCF DCK DDG DDT DEW DFT DHR DIO DIP DIS DJG DJR DKJ DKZ DLZ DMT GTQ JFJ JFL JFM JFP JGG JGS JHW JJE JMO JOB JXM JXN JZJ KHQ KLI KLS KLT KXS KXT LCD LCM LCP LCR LDJ LEG

Regulation Number

862.3030

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

§ 862.3030 Acetaminophen test system.

(a)
Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.(b)
Classification. Class II.

Summary

N/A