The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Emit 2000 Quinidine Assay, Model Osr4q229.
| Device ID | K011605 |
| 510k Number | K011605 |
| Device Name: | EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 |
| Classification | Enzyme Immunoassay, Quinidine |
| Applicant | SYVA CO., DADE BEHRING, INC. 3404 YERBA BUENA RD. San Jose, CA 95135 |
| Contact | Susan Collins |
| Correspondent | Susan Collins SYVA CO., DADE BEHRING, INC. 3404 YERBA BUENA RD. San Jose, CA 95135 |
| Product Code | LBZ |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-24 |
| Decision Date | 2001-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023293 | K011605 | 000 |