The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Multiple Analyte Urine Drugs Of Abuse Calibrators And Controls.
| Device ID | K051088 |
| 510k Number | K051088 |
| Device Name: | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS |
| Classification | Calibrators, Drug Mixture |
| Applicant | Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Contact | Cheng-i Lin |
| Correspondent | Cheng-i Lin Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-28 |
| Decision Date | 2005-06-24 |
| Summary: | summary |