FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

288 results for "Em Diagnostic Systems, Inc."
193–216 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared May 12, 1987
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
K871638 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared May 12, 1987
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
K871329 · LCD
Em Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Apr 23, 1987
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
K871414 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared Apr 22, 1987
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
K871330 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 19d
Cleared Mar 19, 1987
EASY-TEST URIC ACID (URIC) #16606
K870868 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Mar 10, 1987
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615
K870462 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Mar 06, 1987
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX
K870553 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Mar 06, 1987
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614
K870461 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Mar 06, 1987
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
K870170 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Mar 04, 1987
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
K870571 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Mar 04, 1987
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
K870408 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Mar 04, 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Feb 20, 1987
IRON(IRN) TESTPACK, ITEM NO. 67659/95
K870144 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Feb 11, 1987
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
K870247 · DLJ
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Feb 11, 1987
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95
K870143 · JIF
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Jan 09, 1987
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
K864894 · DMT
Em Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jan 08, 1987
EASY-TEST QUINIDINE ITEM NO. 67---/95
K864607 · LBZ
Em Diagnostic Systems, Inc.
Toxicology · 45d
Cleared Jan 08, 1987
EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
K864553 · KLT
Em Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Jan 07, 1987
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95
K864926 · DLZ
Em Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jan 07, 1987
EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95
K864925 · DIP
Em Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jan 07, 1987
EASY-TEST PRIMIDONE ITEM NO. 67---/95
K864554 · DIP
Em Diagnostic Systems, Inc.
Toxicology · 49d
Cleared Dec 31, 1986
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Nov 28, 1986
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
K863963 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Nov 28, 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 49d