The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi Methamphetamine Controls.
| Device ID | K113661 |
| 510k Number | K113661 |
| Device Name: | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS |
| Classification | Gas Chromatography, Methamphetamine |
| 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 | LAF |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-13 |
| Decision Date | 2012-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07603580 | K113661 | 000 |
| 00811727018311 | K113661 | 000 |
| 00811727018328 | K113661 | 000 |
| 00811727018335 | K113661 | 000 |
| 00811727018342 | K113661 | 000 |
| 00811727018359 | K113661 | 000 |
| 00811727018366 | K113661 | 000 |
| 00811727018373 | K113661 | 000 |
| B07603500 | K113661 | 000 |
| B07603510 | K113661 | 000 |
| B07603520 | K113661 | 000 |
| B07603530 | K113661 | 000 |
| B07603540 | K113661 | 000 |
| B07603550 | K113661 | 000 |
| B07603570 | K113661 | 000 |
| 00811727018304 | K113661 | 000 |