METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK

Mixture, Hematology Quality Control

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel Minipak.

Pre-market Notification Details

• Device ID: K042336
• 510k Number: K042336
• Device Name: METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
• Classification: Mixture, Hematology Quality Control
• Applicant: BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine, CA 92618 -2017
• Contact: Maria Zeballos
• Correspondent: Maria Zeballos; BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine, CA 92618 -2017
• Product Code: JPK
• CFR Regulation Number: 864.8625 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-08-30
• Decision Date: 2004-10-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847661003212	K042336	000
00847661003205	K042336	000
00847661003199	K042336	000
00847661003182	K042336	000
00847661003120	K042336	000