FDA 510(k) Premarket Notification K150602: CR3 Keyless Split Sample Cup Morphine - Methamphetamine

Submission Details & Decision

Normalized public record details for 510(k) notification K150602.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K150602

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

CR3 Keyless Split Sample Cup Morphine - Methamphetamine

Product Code

DNK

Decision Date

2015-04-07

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

2015-03-10

Related Establishments / Registrations

TECO DIAGNOSTICS Registration: 1832216 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
JANT PHARMACAL CORP. Registration: 2030633 View Registration
ALFA SCIENTIFIC DESIGNS, INC. Registration: 2060833 View Registration
BTNX Inc. Registration: 3003917514 View Registration
ACRO BIOTECH Inc. Registration: 3005360469 View Registration
LUMIQUICK DIAGNOSTICS, INC. Registration: 3005984081 View Registration
NANTONG EGENS BIOTECHNOLOGY CO.,LTD. Registration: 3006361161 View Registration
ATLAS MEDICAL Registration: 3007126977 View Registration
Chemtron Biotech, Inc. Registration: 3008852306 View Registration
ASSURE TECH. (HANGZHOU) CO., LTD. Registration: 3009585529 View Registration
CO-INNOVATION BIOTECH CO.,LTD. Registration: 3010220539 View Registration
Hangzhou AllTest Biotech Co.,Ltd Registration: 3012073813 View Registration
PREGMATE LLC Registration: 3013679502 View Registration
QuickCo, LTD Registration: 3013684380 View Registration
HOME HEALTH US INCORPORATED Registration: 3021186226 View Registration
CITEST DIAGNOSTICS INC. Registration: 3023296261 View Registration
ACESO LABORATORIES INC. Registration: 3024463179 View Registration
Hangzhou AllTest Biotech Co.,Ltd Registration: 3027519599 View Registration
ABOUND Diagnostics, Inc Registration: 3030413233 View Registration
Hangzhou AllTest Biotech Co.,Ltd Registration: 3043127647 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.