LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6

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 Lzi Oral Fluid 6-acetylmorphine Enzyme Immunoassay, Lzi Oral Fluid 6-acetylmorphine Calibrators (5 Ml), Lzi Oral Fluid 6.

Pre-market Notification Details

• Device ID: K141205
• 510k Number: K141205
• Device Name: LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
• Classification: Enzyme Immunoassay, Opiates
• Applicant: Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085
• Contact: Bernice Lin
• Correspondent: Bernice Lin; Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085
• 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: 2014-05-09
• Decision Date: 2015-02-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B076S02980	K141205	000
B076S02970	K141205	000
B076S02950	K141205	000
B076S02940	K141205	000
B076S02930	K141205	000
B076S02920	K141205	000
B076S02910	K141205	000
B076S02900	K141205	000