Panels › Clinical Toxicology › Product code KXT · Class 2
Enzyme Immunoassay, Digoxin
Regulation 862.3320
0510(k)s in 12 months (85 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in KXT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 31, 1990 | K901216 | ENZYMUN TEST(R) DIGOXIN Boehringer Mannheim Corp. | KXT |
| Feb 13, 1990 | K896863 | DIGOXIN-EIA-XT In Vitro Diagnostics, Inc. | KXT |
| Sep 28, 1989 | K893843 | EZ-BEAD DIGOXIN EIA KIT Immunotech Corp. | KXT |
| Sep 25, 1989 | K894521 | FPR DIGOXIN KIT Colony Laboratories, Inc. | KXT |
| Aug 21, 1989 | K893910 | EMIT CONVENIENCE PACK: DIGOXIN ASSAY Syva Co. | KXT |
| Mar 8, 1989 | K884528 | SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES Heraeus Kulzer, Inc. | KXT |
| Dec 2, 1988 | K884054 | MODIFICATION OF THE CEDIA DIGOXIN ASSAY Microgenics Corp. | KXT |
| Jul 6, 1988 | K882233 | TDX (R) DIGOXIN NXT Abbott Laboratories | KXT |
| May 31, 1988 | K880823 | AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT Amersham Corp. | KXT |
| Aug 28, 1987 | K872583 | CEDIA DIGOXIN CR ASSAY Microgenics Corp. | KXT |
| Aug 28, 1987 | K864223 | IQ DIGOXIN Bd Becton Dickinson Vacutainer Systems Preanalytic | KXT |
| Apr 13, 1987 | K870552 | AFFINITY DIGOXIN IMMUNIT Bd Becton Dickinson Vacutainer Systems Preanalytic | KXT |
| Apr 1, 1987 | K870951 | DIGOXIN FPIA REAGENT SET Sigma Diagnostics, Inc. | KXT |
| Jan 5, 1987 | K864333 | DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY Windsor Laboratories, Inc. | KXT |
| Jul 11, 1986 | K861195 | DELFIA DIGOXIN Lkb Instruments, Inc. | KXT |
| May 29, 1986 | K861394 | EMIT DIGOXIN MOBILE PHASE SOLUTION Syva Co. | KXT |
| May 29, 1986 | K861393 | EMIT COLUMN DIGOXIN ASSAY Syva Co. | KXT |
| Mar 25, 1986 | K854638 | CEDIA DIGOXIN ASSAY Microgenics Corp. | KXT |
| Jan 22, 1986 | K854972 | V-TREND DIG ENZYME IMMUNOASSAY TEST KIT V-Tech, Inc. | KXT |
| Apr 3, 1985 | K851032 | COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C Roche Diagnostic Systems, Inc. | KXT |
| Mar 5, 1985 | K850458 | DUPONT DIGOXIN ASSAY REAGENTS E.I. Dupont DE Nemours & Co., Inc. | KXT |
| Aug 16, 1984 | K842655 | EPSILON DIGOXIN TEST KIT Beckman Instruments, Inc. | KXT |
| Aug 16, 1984 | K842571 | IMMPULSE DIGOXIN ASSAY REAGENTS Aktis Corp. | KXT |
| May 11, 1984 | K841582 | OPTIMATE DIGOXIN TEST Miles Laboratories, Inc. | KXT |
| Apr 19, 1984 | K841107 | ACA DIGOXIN ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. | KXT |
| Mar 12, 1984 | K840673 | SENSIBEAD EIA DIGOXIN KIT Terumo Medical Corp. | KXT |
| Jan 13, 1984 | K833878 | VENTREZYME DIGOXIN IMMUNOASSAY DIGOX Vxr, Inc. | KXT |
| Jan 12, 1984 | K833791 | SYVA ADVANCE DIGOXIN ASSAY Syva Co. | KXT |
| May 17, 1983 | K831177 | STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM- American Dade | KXT |
| Nov 29, 1982 | K823199 | ENZYME-TEST DIGOXIN Icl Scientific | KXT |
| Aug 12, 1981 | K812054 | ENDAB DIGOXIN KIT Immunotech Corp. | KXT |
| Oct 10, 1980 | K802358 | OREIA-Q-DIG Organon, Inc. | KXT |
| Jun 15, 1979 | K790937 | EMIT AUTO DIGOXIN ASSAY Syva Co. | KXT |
| Apr 10, 1979 | K790521 | OREIA - DIGOXIN Organon, Inc. | KXT |
| Mar 19, 1979 | K790303 | EMIT AUTO DIGOXIN ASSAY Syva Co. | KXT |
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