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

Cleared Mar 29, 1990

EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410

K900850 · CHH

Chemistry · 35d

Cleared Mar 19, 1990

SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX

K897176 · CIG

Chemistry · 82d

Cleared Mar 15, 1990

OLYMPUS DIRECT BILIRUBIN

K897175 · CIG

Chemistry · 78d

Cleared Oct 31, 1989

SYSTEMATE(TM) IRON ITEM NUMBER: 65417

K895249 · JIY

Chemistry · 71d

Cleared Oct 31, 1989

SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402

K895250 · CJE

Chemistry · 71d

Cleared Oct 23, 1989

SYSTEMATE CREATININE TEST (CREA) #65413

K895022 · CGX

Chemistry · 76d

Cleared Oct 17, 1989

SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407

K895118 · CIG

Chemistry · 63d

Cleared Oct 17, 1989

SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406

K895119 · CIG

Chemistry · 63d

Cleared Sep 15, 1989

BICARBONATE TEST ITEM NUMBER: 65412

K894509 · KHS

Chemistry · 58d

Cleared Sep 07, 1989

LACTATE DEHYDROGENASE TEST (LD) ITEM #65418

K894482 · CFJ

Chemistry · 51d

Cleared Sep 07, 1989

GLUCOSE-HK TEST (GLU-HK) ITEM #65415

K894483 · CFR

Chemistry · 51d

Cleared Sep 05, 1989

CALCIUM TEST ITEM NUMBER: 65409

K893778 · CIC

Chemistry · 106d

Cleared Aug 31, 1989

EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420

K893915 · CEK

Chemistry · 93d

Cleared Aug 31, 1989

PHOSPHORUS TEST ITEM NUMBER 65416

K894288 · CED

Chemistry · 69d

Cleared Aug 31, 1989

UREA NITROGEN TEST (BUN) ITEM #65408

K894378 · CDQ

Chemistry · 45d

Cleared Aug 31, 1989

MAGNESIUM TEST ITEM NUMBER: 65419

K894508 · JGJ

Chemistry · 43d

Cleared Aug 28, 1989

EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410

K893916 · CHH

Chemistry · 90d

Cleared Aug 28, 1989

EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421

K893917 · CDT

Chemistry · 90d

Cleared Aug 28, 1989

URIC ACID TEST ITEM NUMBER 65422

K894287 · KNK

Chemistry · 66d

Cleared Aug 21, 1989

ALBUMIN TEST (ALB) ITEM NUMBER: 65401

K893777 · CIX

Chemistry · 91d

Cleared Aug 17, 1989

AMYLASE TEST (AML) ITEM NUMBER: 65404

K893751 · JFJ

Chemistry · 90d

Cleared Aug 15, 1989

CHLORIDE STANDARDS ITEM #SR1041

K891999 · JIT

Chemistry · 140d

Cleared Jul 20, 1989

ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403

K893752 · CKA

Chemistry · 62d

Cleared Jul 20, 1989

GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1

K893765 · JQB

Chemistry · 62d

Cleared Jun 09, 1989

LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030

K891574 · JGT

Chemistry · 81d