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

Cleared Nov 10, 1988

LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668

K884548 · CFJ

Chemistry · 10d

Cleared Nov 10, 1988

ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651

K884549 · CJE

Chemistry · 10d

Cleared May 27, 1988

AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693

K881229 · JJY

Chemistry · 66d

Cleared Feb 25, 1988

EASY-TEST POTASSIUM K ITEM NUMBER 19XXX

K880339 · CEJ

Chemistry · 30d

Cleared Jan 21, 1988

EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017

K874586 · CKA

Chemistry · 73d

Cleared Jan 21, 1988

EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010

K874600 · CIT

Chemistry · 73d

Cleared Dec 22, 1987

EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019

K874705 · JEJ

Chemistry · 33d

Cleared Dec 18, 1987

EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008

K874708 · LFR

Chemistry · 29d

Cleared Nov 25, 1987

EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011

K874476 · CEK

Chemistry · 23d

Cleared Nov 24, 1987

EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683

K874397 · LBS

Chemistry · 27d

Cleared Nov 23, 1987

EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010

K874477 · CDQ

Chemistry · 21d

Cleared Nov 06, 1987

EASY-TEST CREATININE (CREA) ITEM NO. 19009

K874088 · CGX

Chemistry · 30d

Cleared Nov 04, 1987

EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687

K874153 · CEO

Chemistry · 22d

Cleared Oct 29, 1987

EASY-TEST SALICYLATE (SAL) #16691

K873425 · DKJ

Chemistry · 65d

Cleared Oct 29, 1987

EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95

K873436 · DLJ

Chemistry · 63d

Cleared Oct 29, 1987

EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021

K873635 · CJE

Chemistry · 50d

Cleared Oct 29, 1987

EASY-TEST ALBUMIN (ALB), ITEM NO. 19039

K873994 · CIX

Chemistry · 28d

Cleared Oct 02, 1987

CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95

K873551 · CIG

Chemistry · 32d

Cleared Sep 29, 1987

ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95

K873681 · CJE

Chemistry · 15d

Cleared Sep 14, 1987

EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690

K873424 · CIG

Chemistry · 20d

Cleared Aug 28, 1987

EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93

K872321 · DKJ

Chemistry · 72d

Cleared Aug 21, 1987

EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95

K872512 · CIG

Chemistry · 58d

Cleared Aug 21, 1987

EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604

K872513 · CIG

Chemistry · 58d

Cleared Aug 13, 1987

EASY ST ANALYZER SYSTEM

K872813 · JJE

Chemistry · 28d

Cleared Jul 27, 1987

EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616

K872320 · JQB

Chemistry · 40d