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 | K023316 |
| 510k Number | K023316 |
| Device Name: | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS |
| Classification | Calibrators, Drug Specific |
| Applicant | Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Synnyvale, CA 94085 -2917 |
| Contact | Chiu Chin Chang |
| Correspondent | Chiu Chin Chang Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Synnyvale, CA 94085 -2917 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-03 |
| Decision Date | 2002-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07601280 | K023316 | 000 |
| 00811727017970 | K023316 | 000 |
| 00811727017963 | K023316 | 000 |
| 00811727017956 | K023316 | 000 |
| 00811727017949 | K023316 | 000 |
| 00811727017932 | K023316 | 000 |
| 00811727017093 | K023316 | 000 |
| 00811727017086 | K023316 | 000 |
| 00811727017079 | K023316 | 000 |
| 00811727017062 | K023316 | 000 |
| 00811727017055 | K023316 | 000 |
| 00811727017987 | K023316 | 000 |
| B07601120 | K023316 | 000 |
| B07601270 | K023316 | 000 |
| B07601250 | K023316 | 000 |
| B07601240 | K023316 | 000 |
| B07601230 | K023316 | 000 |
| B07601220 | K023316 | 000 |
| B07601180 | K023316 | 000 |
| B07601170 | K023316 | 000 |
| B07601150 | K023316 | 000 |
| B07601140 | K023316 | 000 |
| B07601130 | K023316 | 000 |
| 00811727017048 | K023316 | 000 |