PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)

Enzyme Immunoassay, Propoxyphene

Lin-Zhi International, Inc.

The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit).

Pre-market Notification Details

• Device ID: K023795
• 510k Number: K023795
• Device Name: PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
• Classification: Enzyme Immunoassay, Propoxyphene
• Applicant: Lin-Zhi International, Inc. 2391 ZANKER RD., SUITE 340 San Jose, CA 95131 -1124
• Contact: Chiu Chin Chang
• Correspondent: Chiu Chin Chang; Lin-Zhi International, Inc. 2391 ZANKER RD., SUITE 340 San Jose, CA 95131 -1124
• Product Code: JXN
• CFR Regulation Number: 862.3700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-11-13
• Decision Date: 2003-01-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B07601210	K023795	000
B07601200	K023795	000
00811727017925	K023795	000
00811727017918	K023795	000