BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS

Enzyme Immunoassay, Opiates

Lin-Zhi International, Inc.

The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Buprenorphine Enzyme Immunoassay With Norbuprenorphine Calibrators And Controls.

Pre-market Notification Details

• Device ID: K090844
• 510k Number: K090844
• Device Name: BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
• Classification: Enzyme Immunoassay, Opiates
• Applicant: Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917
• Contact: Marie Lin
• Correspondent: Marie Lin; Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917
• Product Code: DJG
• Subsequent Product Code: DLJ
• Subsequent Product Code: LAS
• CFR Regulation Number: 862.3650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-27
• Decision Date: 2009-07-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811727016393	K090844	000
00811727016317	K090844	000
00811727016324	K090844	000
00811727016331	K090844	000
00811727016348	K090844	000
00811727016355	K090844	000
00811727016362	K090844	000
00811727016379	K090844	000
00811727016386	K090844	000
00811727016300	K090844	000