Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
288
Total
288
Cleared
0
Denied
23 devices
Cleared
Aug 23, 1988
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
Toxicology
48d
Cleared
Aug 08, 1988
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
Toxicology
38d
Cleared
Jun 01, 1988
EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647
Toxicology
50d
Cleared
May 27, 1988
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
Toxicology
59d
Cleared
Nov 09, 1987
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95
Toxicology
32d
Cleared
Nov 05, 1987
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95
Toxicology
28d
Cleared
Oct 29, 1987
EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
Toxicology
65d
Cleared
Sep 29, 1987
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
Toxicology
40d
Cleared
Sep 22, 1987
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649
Toxicology
33d
Cleared
Jul 09, 1987
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95
Toxicology
22d
Cleared
May 12, 1987
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
Toxicology
39d
Cleared
Apr 22, 1987
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
Toxicology
19d
Cleared
Jan 09, 1987
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
Toxicology
25d
Cleared
Jan 08, 1987
EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
Toxicology
50d
Cleared
Jan 08, 1987
EASY-TEST QUINIDINE ITEM NO. 67---/95
Toxicology
45d
Cleared
Jan 07, 1987
EASY-TEST PRIMIDONE ITEM NO. 67---/95
Toxicology
49d
Cleared
Jan 07, 1987
EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95
Toxicology
22d
Cleared
Jan 07, 1987
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95
Toxicology
22d
Cleared
Nov 25, 1986
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
Toxicology
40d
Cleared
Sep 29, 1986
EMDS(TM) ALCOHOL TESTPACKS, #67691/95
Toxicology
26d
Cleared
Jul 07, 1986
EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93
Toxicology
20d
Cleared
Jul 07, 1986
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93
Toxicology
17d
Cleared
Jul 07, 1986
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
Toxicology
17d