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."
145–168 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared Jan 11, 1989
ALBUMIN TEST (ALB) ITEM #65650
K884705 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Jan 11, 1989
AMYLASE TEST (AMYL) ITEM NUMBER: 65653
K884382 · CIW
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jan 11, 1989
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
K884376 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jan 03, 1989
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665
K884736 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Dec 19, 1988
CREATININE TEST (CREA) ITEM #65663
K884734 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Dec 16, 1988
PHOSPHORUS TEST (PHOS) ITEM #65666
K884735 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Dec 14, 1988
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654
K884377 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Nov 10, 1988
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
K884549 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Nov 10, 1988
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
K884548 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Nov 10, 1988
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
K884021 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Aug 23, 1988
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
K882766 · DLG
Em Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Aug 08, 1988
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · LDP
Em Diagnostic Systems, Inc.
Toxicology · 38d
Cleared Jun 01, 1988
EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647
K881607 · DLF
Em Diagnostic Systems, Inc.
Toxicology · 50d
Cleared May 27, 1988
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
K881337 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 59d
Cleared May 27, 1988
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
K881229 · JJY
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Mar 11, 1988
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
K880003 · DHB
Em Diagnostic Systems, Inc.
Immunology · 67d
Cleared Feb 25, 1988
EASY-TEST POTASSIUM K ITEM NUMBER 19XXX
K880339 · CEJ
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Feb 11, 1988
EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628
K875062 · GJS
Em Diagnostic Systems, Inc.
Hematology · 64d
Cleared Jan 21, 1988
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
K874600 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Jan 21, 1988
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017
K874586 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Dec 22, 1987
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019
K874705 · JEJ
Em Diagnostic Systems, Inc.
Chemistry · 33d
Cleared Dec 18, 1987
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
K874708 · LFR
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Nov 25, 1987
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Nov 24, 1987
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
K874397 · LBS
Em Diagnostic Systems, Inc.
Chemistry · 27d