QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS

Urinalysis Controls (assayed And Unassayed)

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Quantify Control And Quantify Plus Controls.

Pre-market Notification Details

• Device ID: K042446
• 510k Number: K042446
• Device Name: QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
• Classification: Urinalysis Controls (assayed And Unassayed)
• 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: JJW
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-09-09
• Decision Date: 2004-11-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847661003298	K042446	000
00847661003281	K042446	000
00847661003274	K042446	000
00847661003267	K042446	000
00847661003250	K042446	000
00847661003243	K042446	000
00847661003236	K042446	000
00847661003229	K042446	000