The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Multiple Analyte Set A;b;c Drugs Of Abuse Controls.
| Device ID | K133710 |
| 510k Number | K133710 |
| Device Name: | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS |
| Classification | Calibrators, Drug Mixture |
| Applicant | Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085 |
| Contact | Bernice Lin |
| Correspondent | Bernice Lin Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-04 |
| Decision Date | 2014-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091675 | K133710 | 000 |
| B07608330 | K133710 | 000 |
| B07608320 | K133710 | 000 |
| B07608180 | K133710 | 000 |
| B07608170 | K133710 | 000 |
| B07608150 | K133710 | 000 |
| B07608140 | K133710 | 000 |
| B07608130 | K133710 | 000 |
| B07608120 | K133710 | 000 |
| 00811727017604 | K133710 | 000 |
| 00811727017598 | K133710 | 000 |
| 00811727017581 | K133710 | 000 |
| 00811727017574 | K133710 | 000 |
| 00811727017567 | K133710 | 000 |
| 00811727017550 | K133710 | 000 |
| B07608340 | K133710 | 000 |
| B07608350 | K133710 | 000 |
| 05060500091668 | K133710 | 000 |
| 05060500091651 | K133710 | 000 |
| 05060500091644 | K133710 | 000 |
| 05060500091637 | K133710 | 000 |
| 05060500091620 | K133710 | 000 |
| 05060500091613 | K133710 | 000 |
| B07608580 | K133710 | 000 |
| B07608570 | K133710 | 000 |
| B07608550 | K133710 | 000 |
| B07608540 | K133710 | 000 |
| B07608530 | K133710 | 000 |
| B07608520 | K133710 | 000 |
| B07608380 | K133710 | 000 |
| B07608370 | K133710 | 000 |
| 00811727016850 | K133710 | 000 |