The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Cannabinoid Urine Drugs Of Abuse Calibrators And Controls.
| Device ID | K021449 |
| 510k Number | K021449 |
| Device Name: | CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS |
| Classification | Calibrators, Drug Specific |
| Applicant | Lin-Zhi International, Inc. 2391 ZANKER RD., SUITE 340 San Jose, CA 95131 -1124 |
| Contact | Chin Chin Chang |
| Correspondent | Chin Chin Chang Lin-Zhi International, Inc. 2391 ZANKER RD., SUITE 340 San Jose, CA 95131 -1124 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-06 |
| Decision Date | 2002-06-18 |
| Summary: | summary |