MISSION U500 URINE ANALYZER

Blood, Occult, Colorimetric, In Urine

ACON LABORATORIES, INC.

The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Mission U500 Urine Analyzer.

Pre-market Notification Details

• Device ID: K111221
• 510k Number: K111221
• Device Name: MISSION U500 URINE ANALYZER
• Classification: Blood, Occult, Colorimetric, In Urine
• Applicant: ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego, CA 92121
• Contact: Qiyi Xie
• Correspondent: Qiyi Xie; ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego, CA 92121
• Product Code: JIO
• Subsequent Product Code: CDM
• Subsequent Product Code: CEN
• Subsequent Product Code: JIL
• Subsequent Product Code: JIN
• Subsequent Product Code: JIR
• Subsequent Product Code: JJB
• Subsequent Product Code: JMA
• Subsequent Product Code: JRE
• Subsequent Product Code: KQO
• Subsequent Product Code: LJX
• Subsequent Product Code: NGJ
• CFR Regulation Number: 864.6550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-05-02
• Decision Date: 2012-01-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00722066001219	K111221	000
20682607200515	K111221	000
20682607200508	K111221	000