The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Bmbp Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit).
| Device ID | K033885 |
| 510k Number | K033885 |
| Device Name: | BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Contact | Cheng-i Lin, Ph.d. |
| Correspondent | Cheng-i Lin, Ph.d. Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Product Code | DIS |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-15 |
| Decision Date | 2004-05-19 |
| Summary: | summary |