American Dade

FDA Filings

This page includes the latest FDA filings for American Dade. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMN K873051 AMERICAN DADE	STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY	1987-10-20
PMN K873171 AMERICAN DADE	STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY	1987-09-29
PMN K873052 AMERICAN DADE	STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY	1987-09-14
PMN K872789 AMERICAN DADE	PARAMAX URINE/CSF CALIBRATOR	1987-09-02
PMN K872195 AMERICAN DADE	DATA-FI DIMERTEST LATEX ASSAY	1987-08-06
PMN K872196 AMERICAN DADE	AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III	1987-07-31
PMN K871972 AMERICAN DADE	STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY	1987-07-21
PMN K871977 AMERICAN DADE	DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR	1987-07-09
PMN K872050 AMERICAN DADE	PARAMAX CHOLESTEROL REAGENT	1987-07-07
PMN K872360 AMERICAN DADE	DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET	1987-07-06
PMN K870158 AMERICAN DADE	STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.	1987-03-19
PMN K870406 AMERICAN DADE	SMI DIGITRON	1987-02-25
PMN K870354 AMERICAN DADE	IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)	1987-02-10
PMN K870353 AMERICAN DADE	IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)	1987-02-10
PMN K864274 AMERICAN DADE	THROMBOPLASTIN.R	1986-11-13
PMN K864273 AMERICAN DADE	THROMBOPLASTIN.C	1986-11-13
PMN K864272 AMERICAN DADE	THROMBOPLASTIN.FS	1986-11-13
PMN K863887 AMERICAN DADE	SMI MULTIPETTOR(TM)	1986-11-05
PMN K863594 AMERICAN DADE	ACTIN FSL ACTIVATED PTT REAGENT	1986-10-17
PMN K863489 AMERICAN DADE	PARAMAX ELECTROLYTE CALIBRATOR	1986-09-29
PMN K862818 AMERICAN DADE	STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY	1986-08-19
PMN K862428 AMERICAN DADE	STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY	1986-08-19
PMN K862440 AMERICAN DADE	PARAMAX LIPASE REAGENT	1986-08-04
PMN K862067 AMERICAN DADE	STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY	1986-06-16
PMN K860906 AMERICAN DADE	STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III	1986-05-29
PMN K860422 AMERICAN DADE	STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY	1986-04-11
PMN K860355 AMERICAN DADE	BOVINE CHEMISTRY CONTROL I.X AND II.X	1986-03-17
PMN K855199 AMERICAN DADE	PARAMAX COMPREHENSIVE CALIBRATOR	1986-02-19
PMN K860421 AMERICAN DADE	STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY	1986-02-11
PMN K860141 AMERICAN DADE	STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.	1986-02-11
PMN K860140 AMERICAN DADE	STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.	1986-02-06
PMN K854651 AMERICAN DADE	PARAAMAX CHLORIDE DETERMINATION BY ISE	1985-12-13
PMN K853986 AMERICAN DADE	THROMBOPLASTIN-R REAGENT	1985-11-12
PMN K853548 AMERICAN DADE	STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS	1985-09-18
PMN K853547 AMERICAN DADE	STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I	1985-09-16
PMN K853531 AMERICAN DADE	ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER	1985-09-04
PMN K853462 AMERICAN DADE	COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA	1985-08-29
PMN K853461 AMERICAN DADE	COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA	1985-08-29
PMN K852285 AMERICAN DADE	DADE BLOOD GAS AMPUL INJECTOR	1985-07-09
PMN K850574 AMERICAN DADE	DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO	1985-04-12
PMN K850575 AMERICAN DADE	DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H	1985-04-10
PMN K850570 AMERICAN DADE	STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY	1985-04-02
PMN K844289 AMERICAN DADE	SERIES I/S INFECTIONS	1984-11-19
PMN K844158 AMERICAN DADE	STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY	1984-11-19
PMN K842617 AMERICAN DADE	VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT	1984-10-01
PMN K842537 AMERICAN DADE	VON WILLEBRAND FACTOR ANTIGEN SCREEN	1984-10-01
PMN K843184 AMERICAN DADE	STRATUS LIDOCAINE FLUOROMETRIC ENZYME	1984-09-26
PMN K843183 AMERICAN DADE	STRATUS CORTISOL FLUOROMETRIC ENZYME	1984-09-17
PMN K843237 AMERICAN DADE	STRATUS QUINIDINE FLUOROMETRIC ENZYME	1984-09-12
PMN K842196 AMERICAN DADE	STRATUS PRIMIDONE FLOROMETRIC ENZY	1984-07-11
PMN K841887 AMERICAN DADE	PARAMAX IRON BLANK REAGENT	1984-06-22
PMN K841886 AMERICAN DADE	PARAMAX IRON REAGENT	1984-06-22
PMN K841439 AMERICAN DADE	COMA TOXICOLOGY CONTROL	1984-05-16
PMN K841364 AMERICAN DADE	COAGULATION FACTOR V DEFICIENT SUBSTR	1984-04-25
PMN K841047 AMERICAN DADE	PARAMAX CHLORIDE REAGENT	1984-04-19
PMN K840010 AMERICAN DADE	DADE HEMATOLOGY CALIBRATOR PLUS	1984-04-19
PMN K845052 AMERICAN DADE	PARAMAX TOTAL PROTEIN REAGENT TP	1984-04-13
PMN K840784 AMERICAN DADE	PARAMAX MAGNESIUM REAGENT	1984-04-13
PMN K840782 AMERICAN DADE	ALBUMIN REAGENT	1984-04-13
PMN K840781 AMERICAN DADE	URIC ACID REAGENT	1984-04-13
PMN K840779 AMERICAN DADE	NEONATAL BILIRUBIN REAGENT	1984-04-13
PMN K840778 AMERICAN DADE	LACTATE REAGENT	1984-04-13
PMN K840772 AMERICAN DADE	ALCOHOL & AMMONIA CALIBRATOR II	1984-04-13
PMN K840771 AMERICAN DADE	ALCOHOL & AMMONIA CALIBRATOR I	1984-04-13
PMN K840769 AMERICAN DADE	PARAMAX ALCOHOL REAGENT	1984-04-13
PMN K840785 AMERICAN DADE	PARAMAX UREA NITROGEN REAGENT	1984-04-05
PMN K840780 AMERICAN DADE	TRIGLYCERIDES REAGENT	1984-04-05
PMN K840777 AMERICAN DADE	DIRECT BILIRUBIN REAGENT	1984-04-05
PMN K840783 AMERICAN DADE	CREATINE KINASE MB REAGENT	1984-04-04
PMN K840776 AMERICAN DADE	PARAMAX CHOLESTEROL REAGENT	1984-04-04
PMN K840775 AMERICAN DADE	CARBON DIOXIDE CALIBRATOR II	1984-04-04
PMN K840774 AMERICAN DADE	CARBON DIOXIDE CALIBRATOR I	1984-04-04
PMN K840773 AMERICAN DADE	CARBON DIOXIDE REAGENT	1984-04-04
PMN K840770 AMERICAN DADE	PARAMAX AMMONIA REAGENTT	1984-04-04
PMN K840706 AMERICAN DADE	ASPARTATE AMINOTRANSFERASE REAGENT	1984-04-04
PMN K840661 AMERICAN DADE	PARAMAX ACID PHOSPHATASE REAGENT	1984-04-04
PMN K840705 AMERICAN DADE	PARAMAX ALANINE AMINOTRANSFERASE	1984-03-09
PMN K834209 AMERICAN DADE	STRATUS THYROID UPTAKE FLUOROMETRIC	1984-03-09
PMN K834210 AMERICAN DADE	STRATUS TOTAL THYROXINE FLUOROMETRIC	1984-03-05
PMN K834051 AMERICAN DADE	PROTOPATH FACTOR VIII ASSAY	1984-02-04
PMN K834050 AMERICAN DADE	PROTOPATH FACTOR IX ASSAY	1984-02-04
PMN K832965 AMERICAN DADE	STRATUS THEOPHYLLINE ASSAY	1983-12-30
PMN K833353 AMERICAN DADE	ACLAIM-QAP IBM PERSONAL COMPUTER EDT	1983-12-22
PMN K833005 AMERICAN DADE	PARAMAX BILIRUBIN CALIBRATORS	1983-11-14
PMN K833272 AMERICAN DADE	THROMBOPLASTIN - FS	1983-11-03
PMN K833003 AMERICAN DADE	PARAMAX SALICYLATE REAGENT	1983-10-28
PMN K833004 AMERICAN DADE	PARAMAX TOTAL BILIRUBIN REAGENT	1983-10-14
PMN K833002 AMERICAN DADE	PARAMAX PHOSPHORUS REAGENT	1983-10-14
PMN K833001 AMERICAN DADE	PARAMAX & GLUTAMYTRANSFERASE REAGENT	1983-10-14
PMN K832708 AMERICAN DADE	PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS	1983-10-14
PMN K832447 AMERICAN DADE	STRATUS CARBAMAZEPINE FLUROMETRIC	1983-09-12
PMN K832445 AMERICAN DADE	STRATUS GENTAMICIN FLUOROMETRIC ENZYM	1983-08-31
PMN K832336 AMERICAN DADE	STRATUS AMIKACIN FLUOROMETRIC	1983-08-31
PMN K832408 AMERICAN DADE	STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM	1983-08-26
PMN K832003 AMERICAN DADE	AQUEOUS BLOOD GAS CONTROL LEVEL I,II &	1983-08-10
PMN K831537 AMERICAN DADE	PARAMAX CREATINE KINASE REAGENT	1983-06-22
PMN K831480 AMERICAN DADE	PARAMAX ALKALINE PHOSPHATASE REAGENT-	1983-06-22
PMN K831536 AMERICAN DADE	PARAMAX AMALINE REAGENT	1983-06-17
PMN K831297 AMERICAN DADE	PROTOTRO/PROTEOLYTIC ENZYME CONTROL	1983-06-08
PMN K831140 AMERICAN DADE	DADE HEMATOLOGY CALIBRATOR	1983-06-08