The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Barbiturate Enzyme Immunoassay, Ca. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit).
| Device ID | K032764 |
| 510k Number | K032764 |
| Device Name: | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-05 |
| Decision Date | 2003-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07601460 | K032764 | 000 |
| 00811727017185 | K032764 | 000 |
| 00811727017192 | K032764 | 000 |
| 00811727017208 | K032764 | 000 |
| 00811727017215 | K032764 | 000 |
| 00811727017222 | K032764 | 000 |
| 00811727017239 | K032764 | 000 |
| B07601400 | K032764 | 000 |
| B07601410 | K032764 | 000 |
| B07601420 | K032764 | 000 |
| B07601430 | K032764 | 000 |
| B07601440 | K032764 | 000 |
| B07601450 | K032764 | 000 |
| 00811727017178 | K032764 | 000 |