The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Single Analyte Urine Drugs Of Abuse Calibrators And Controls.
| Device ID | K020769 |
| 510k Number | K020769 |
| Device Name: | SINGLE ANALYTE 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 | Chiu Chin Chang |
| Correspondent | Chiu 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 | 2002-03-07 |
| Decision Date | 2002-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727016478 | K020769 | 000 |
| 00811727016898 | K020769 | 000 |
| 00811727016904 | K020769 | 000 |
| 00811727016911 | K020769 | 000 |
| 00811727016928 | K020769 | 000 |
| 00811727016935 | K020769 | 000 |
| 00811727017772 | K020769 | 000 |
| 00811727017789 | K020769 | 000 |
| 00811727017796 | K020769 | 000 |
| 00811727017802 | K020769 | 000 |
| 00811727017819 | K020769 | 000 |
| 00811727016881 | K020769 | 000 |
| 00811727016683 | K020769 | 000 |
| 00811727016485 | K020769 | 000 |
| 00811727016492 | K020769 | 000 |
| 00811727016508 | K020769 | 000 |
| 00811727016515 | K020769 | 000 |
| 00811727016522 | K020769 | 000 |
| 00811727016638 | K020769 | 000 |
| 00811727016645 | K020769 | 000 |
| 00811727016652 | K020769 | 000 |
| 00811727016669 | K020769 | 000 |
| 00811727016676 | K020769 | 000 |
| 00811727017826 | K020769 | 000 |
| B07600120 | K020769 | 000 |
| B07600330 | K020769 | 000 |
| B07600340 | K020769 | 000 |
| B07600350 | K020769 | 000 |
| B07600370 | K020769 | 000 |
| B07600380 | K020769 | 000 |
| B07600420 | K020769 | 000 |
| B07600430 | K020769 | 000 |
| B07600440 | K020769 | 000 |
| B07600450 | K020769 | 000 |
| B07600470 | K020769 | 000 |
| B07600320 | K020769 | 000 |
| B07600280 | K020769 | 000 |
| B07600130 | K020769 | 000 |
| B07600140 | K020769 | 000 |
| B07600150 | K020769 | 000 |
| B07600170 | K020769 | 000 |
| B07600180 | K020769 | 000 |
| B07600220 | K020769 | 000 |
| B07600230 | K020769 | 000 |
| B07600240 | K020769 | 000 |
| B07600250 | K020769 | 000 |
| B07600270 | K020769 | 000 |
| B07600480 | K020769 | 000 |