The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators; Lzi Amphetamines 500 Controls.
| Device ID | K102210 |
| 510k Number | K102210 |
| Device Name: | LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Lin-Zhi International, Inc. 670 ALmanor Avenue Sunnyvale, CA 94085 |
| Contact | Bernice Lin |
| Correspondent | Bernice Lin Lin-Zhi International, Inc. 670 ALmanor Avenue Sunnyvale, CA 94085 |
| Product Code | DKZ |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-05 |
| Decision Date | 2010-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07601080 | K102210 | 000 |
| 00811727016546 | K102210 | 000 |
| 00811727016553 | K102210 | 000 |
| 00811727016560 | K102210 | 000 |
| 00811727016577 | K102210 | 000 |
| 00811727016584 | K102210 | 000 |
| 00811727016591 | K102210 | 000 |
| 00811727016607 | K102210 | 000 |
| B07601000 | K102210 | 000 |
| B07601010 | K102210 | 000 |
| B07601020 | K102210 | 000 |
| B07601030 | K102210 | 000 |
| B07601040 | K102210 | 000 |
| B07601050 | K102210 | 000 |
| B07601070 | K102210 | 000 |
| 00811727016539 | K102210 | 000 |