The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Phencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011.
| Device ID | K020254 |
| 510k Number | K020254 |
| Device Name: | PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | Lin-Zhi International, Inc. 2391 ZANKER RD. SUITE 340 San Jose, CA 95131 |
| Contact | Chiu Chin Chang |
| Correspondent | Chiu Chin Chang Lin-Zhi International, Inc. 2391 ZANKER RD. SUITE 340 San Jose, CA 95131 |
| Product Code | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-24 |
| Decision Date | 2002-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07600110 | K020254 | 000 |
| B07600100 | K020254 | 000 |
| 00811727016461 | K020254 | 000 |
| 00811727016454 | K020254 | 000 |