The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators And Controls.
Device ID | K050988 |
510k Number | K050988 |
Device Name: | OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS |
Classification | Coating, Liquid, Glc |
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 | DLG |
Subsequent Product Code | DLJ |
Subsequent Product Code | LAS |
CFR Regulation Number | 862.2250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-19 |
Decision Date | 2006-04-06 |
Summary: | summary |