The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Ecstasy Enzyme Immunoassay, Catalog # 0160 (500 Test Kit), Catalog # 0161 (5000 Test Kit).
| Device ID | K033094 |
| 510k Number | K033094 |
| Device Name: | ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Contact | Cheng-i Lin |
| Correspondent | Cheng-i Lin Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| 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 | 2003-09-29 |
| Decision Date | 2003-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07601680 | K033094 | 000 |
| 00811727018007 | K033094 | 000 |
| 00811727018014 | K033094 | 000 |
| 00811727018021 | K033094 | 000 |
| 00811727018038 | K033094 | 000 |
| 00811727018045 | K033094 | 000 |
| 00811727018052 | K033094 | 000 |
| 00811727018069 | K033094 | 000 |
| B07601600 | K033094 | 000 |
| B07601610 | K033094 | 000 |
| B07601620 | K033094 | 000 |
| B07601630 | K033094 | 000 |
| B07601640 | K033094 | 000 |
| B07601650 | K033094 | 000 |
| B07601670 | K033094 | 000 |
| 00811727017994 | K033094 | 000 |