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."
217–240 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared Nov 25, 1986
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
K864041 · KLS
Em Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Nov 05, 1986
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95
K863738 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Oct 29, 1986
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95
K863718 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Oct 29, 1986
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95
K863660 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 41d
Cleared Oct 29, 1986
CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95
K863478 · JGQ
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Sep 29, 1986
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
K863544 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 29, 1986
EMDS(TM) ALCOHOL TESTPACKS, #67691/95
K863419 · DML
Em Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Sep 26, 1986
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
K863477 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 25, 1986
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
K863545 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 13d
Cleared Sep 16, 1986
EMDS(TM) ALBUMIN TESTPACKS, #67652/95
K863004 · CJW
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Sep 16, 1986
EMDS(TM) CALCIUM TESTPACKS, #67687/95
K863003 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Aug 29, 1986
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
K863094 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Aug 29, 1986
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
K863005 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Aug 29, 1986
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
K862845 · LBS
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Aug 19, 1986
EMDS(TM) MAGNESIUM TESTPACKS, #67671/95
K863002 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 11d
Cleared Aug 19, 1986
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
K862707 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Aug 19, 1986
EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
K862706 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Aug 19, 1986
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
K862704 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Aug 19, 1986
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
K862525 · JIT
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Aug 19, 1986
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
K862453 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 53d
Cleared Aug 04, 1986
EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95
K862703 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Jul 07, 1986
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
K862350 · KLS
Em Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Jul 07, 1986
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93
K862349 · DIP
Em Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Jul 07, 1986
EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93
K862308 · DLZ
Em Diagnostic Systems, Inc.
Toxicology · 20d