Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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