The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage System Digoxin (dig) Reagent/beckman Drug Calibrator 2.
| Device ID | K963062 |
| 510k Number | K963062 |
| Device Name: | IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. M.S. W-351 Brea, CA 92621 |
| Contact | Margie George |
| Correspondent | Margie George BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. M.S. W-351 Brea, CA 92621 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-07 |
| Decision Date | 1996-12-13 |
| Summary: | summary |