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 |