Medical Device Manufacturer · US , Walker , MI

Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

288 submissions · 288 cleared · Since 1984

Recent clearances: ASPARTATE AMINOTRANSFERASE (AST) TEST, ALANINE AMINOTRANSFERASE (ALT) TEST, EMDS PHOSPHOROUS (PHOS) TEST

288

Total

288

Cleared

0

Denied

FDA 510(k) Regulatory Record - Em Diagnostic Systems, Inc. Toxicology ✕

23 devices

1-12 of 23

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