The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System Tdm (car,phe,phy, & The) Reagents.
| Device ID | K963673 |
| 510k Number | K963673 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | KLT |
| Subsequent Product Code | DKB |
| Subsequent Product Code | LGQ |
| Subsequent Product Code | LGR |
| Subsequent Product Code | LGS |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-13 |
| Decision Date | 1997-02-04 |
| Summary: | summary |