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Panels › Clinical Toxicology › Product code DLJ · Class 2

Calibrators, Drug Specific

Regulation 862.3200

0510(k)s in 12 months (123 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
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Top companies in DLJ

Company510(k)sRecalls
E.I. Dupont DE Nemours & Co., Inc.210
Syva Co.180
Innotron of Oregon, Inc.100
Dade Behring, Inc.80
Roche Diagnostic Systems, Inc.80
Diagnostic Reagents, Inc.70
Microgenics Corp.52
Em Diagnostic Systems, Inc.60
Colony Laboratories, Inc.50
Lin-Zhi International, Inc.31
Decided510(k)Device and applicantCode
Apr 19, 1984K841108ACA DIGOXIN CALLIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
DLJ
Mar 23, 1984K840597QUINIDINE CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
DLJ
Mar 19, 1984K833977SERALYZER DRUG ASSAY CONTROL SERUM
Miles Laboratories, Inc.
DLJ
Dec 27, 1983K833383PROCAINAMIDE CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
DLJ
Dec 27, 1983K833382VALPROIC ACID CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
DLJ
Dec 27, 1983K833380LIDOAINE CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
DLJ
Oct 27, 1983K832982ACA TOBRAMYCIN CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
DLJ
Jul 19, 1983K831980EMIT SERUM TRICYCLIC ANTIDEPRESS CALIBRA
Syva Co.
DLJ
Jul 19, 1983K831933THEOPHYLLINE ACA CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
DLJ
May 16, 1983K831209GENTAMICIN CALIBRATOR -ACA
E.I. Dupont DE Nemours & Co., Inc.
DLJ
Sep 21, 1982K822587ADVANCE EMIT-CAD QUINIDINE CONTROL
Syva Co.
DLJ
Jul 27, 1982K822052EMIT D.A.V. METHAQUALONE URINE CALIBRA
Syva Co.
DLJ
Aug 20, 1981K812197EMIT-ST CANNABINOID CALIBRATOR
Syva Co.
DLJ
Jun 25, 1981K811622EMIT-ST SERUM PHENOBARBITAL CALIBRATOR
Syva Co.
DLJ
Feb 26, 1980K800247EMIT -D.A.U. CANNABINOID URINE CALIBS.
Syva Co.
DLJ
Jun 15, 1979K790399URINE MEDIUM CALIBRATOR
Syva Co.
DLJ
Jun 15, 1979K790398EMIT-D.A.U. PHENCYCLIDINE URINE LOW
Syva Co.
DLJ
Jan 17, 1979K780731LIDOCAINE CALIBRATOR KIT
Vitek Systems, Inc.
DLJ
Nov 22, 1978K780732PROCAINAMIDE CALIBRATOR KIT
Vitek Systems, Inc.
DLJ
Nov 22, 1977K772167EMIT LIDOCAINE CONTROL
Syva Co.
DLJ
Nov 22, 1977K772166EMIT THEOPHYLLINE CONTROL
Syva Co.
DLJ
Oct 4, 1977K771805ACA SALICYLATE CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
DLJ
Oct 4, 1977K771799ACA ALCOHOL CALIBRATORS
E.I. Dupont DE Nemours & Co., Inc.
DLJ

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