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

Cleared Jun 07, 1989

EASY-TEST IRON (IRON) ITEM NO. 16686

K892863 · JIY

Chemistry · 50d

Cleared Mar 31, 1989

REVISED MAGNESIUM TEST ITEM NUMBER: SR1019

K890798 · JGJ

Chemistry · 42d

Cleared Feb 17, 1989

CHOLESTEROL TEST ITEM NUMBER: SR1011

K885023 · CHH

Chemistry · 74d

Cleared Feb 17, 1989

BICARBONATE TEST ITEM NUMBER: SR1006

K890305 · KHS

Chemistry · 25d

Cleared Feb 10, 1989

CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673

K884547 · CGS

Chemistry · 102d

Cleared Feb 10, 1989

HDL CHOLESTEROL TEST

K885265 · LBR

Chemistry · 50d

Cleared Feb 10, 1989

IRON REAGENTS ITEM NUMBER: SR1017

K890304 · JIY

Chemistry · 18d

Cleared Feb 07, 1989

OLYMPUS TRIGLYCERIDES REAGENTS #SR1021

K885266 · CDT

Chemistry · 47d

Cleared Feb 02, 1989

CREATINE KINASE TEST (CK) ITEM NUMBER: 65661

K884546 · CGS

Chemistry · 94d

Cleared Jan 30, 1989

TOTAL BILIRUBIN TEST CATALOG NO. SR1007

K885284 · CIG

Chemistry · 38d

Cleared Jan 30, 1989

DIRECT BILIRUBIN TEST CATALOG NO. SR1008

K885285 · CIG

Chemistry · 38d

Cleared Jan 27, 1989

EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629

K884702 · GFO

Hematology · 79d

Cleared Jan 23, 1989

TOTAL PROTEIN TEST (TP) ITEM #65670

K884703 · CEK

Chemistry · 75d

Cleared Jan 23, 1989

URIC ACID TEST (URIC) ITEM #65620

K884704 · KNK

Chemistry · 75d

Cleared Jan 17, 1989

MAGNESIUM TEST ITEM NUMBER: SR1019

K885022 · JGJ

Chemistry · 43d

Cleared Jan 13, 1989

CALCIUM TEST ITEM NUMBER: SR1009

K884986 · CIC

Chemistry · 43d

Cleared Jan 13, 1989

UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022

K884987 · CDQ

Chemistry · 43d

Cleared Jan 13, 1989

GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664

K884988 · JQB

Chemistry · 43d

Cleared Jan 11, 1989

ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652

K884376 · CKA

Chemistry · 85d

Cleared Jan 11, 1989

AMYLASE TEST (AMYL) ITEM NUMBER: 65653

K884382 · CIW

Chemistry · 85d

Cleared Jan 11, 1989

ALBUMIN TEST (ALB) ITEM #65650

K884705 · CIX

Chemistry · 63d

Cleared Jan 11, 1989

CHLORIDE TEST (CL) ITEM #65659

K884706 · CHJ

Chemistry · 63d

Cleared Jan 03, 1989

GLUCOSE-HK TEST (GLUC-HK) ITEM #65665

K884736 · CFR

Chemistry · 50d

Cleared Dec 19, 1988

CREATININE TEST (CREA) ITEM #65663

K884734 · CGX

Chemistry · 35d

Cleared Dec 16, 1988

PHOSPHORUS TEST (PHOS) ITEM #65666

K884735 · CEO

Chemistry · 32d