Em Diagnostic Systems, Inc.
FDA 510(k) medical device clearances.
Clearances by Em Diagnostic Systems, Inc. — page 3
201–288 of 288- K870553 — EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX
- K870407 — EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
- K870408 — EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
- K870571 — EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
- K870144 — IRON(IRN) TESTPACK, ITEM NO. 67659/95
- K870143 — AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95
- K870247 — EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
- K864894 — EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
- K864553 — EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
- K864607 — EASY-TEST QUINIDINE ITEM NO. 67---/95
- K864554 — EASY-TEST PRIMIDONE ITEM NO. 67---/95
- K864925 — EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95
- K864926 — EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95
- K864715 — EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
- K863962 — EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
- K863963 — EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
- K864041 — EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
- K863738 — EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95
- K863478 — CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95
- K863660 — EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95
- K863718 — EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95
- K863419 — EMDS(TM) ALCOHOL TESTPACKS, #67691/95
- K863544 — EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
- K863477 — EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
- K863545 — EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
- K863003 — EMDS(TM) CALCIUM TESTPACKS, #67687/95
- K863004 — EMDS(TM) ALBUMIN TESTPACKS, #67652/95
- K862845 — EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
- K863005 — EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
- K863094 — SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
- K862453 — EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
- K862525 — EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
- K862704 — EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
- K862706 — EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
- K862707 — EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
- K863002 — EMDS(TM) MAGNESIUM TESTPACKS, #67671/95
- K862703 — EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95
- K862308 — EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93
- K862349 — EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93
- K862350 — EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
- K860935 — EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
- K861512 — EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
- K861055 — EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95
- K861061 — EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK
- K861221 — EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
- K860640 — EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93
- K860668 — ION-SPECIFIC ELECTRODE, CHLORIDE
- K860669 — CREATINE KINASE, N-ACETYL-L-CYSTIENE
- K860764 — EMDS ENZYME VERIFIER, LEVELS I & II
- K860765 — EMDS CHEMISTRY CALIBRATORS, LEVELS I & II
- K860916 — EASY-TEST URIC ACID (URIC), #67516/93
- K860917 — EASY-TEST TOTAL PROTEIN (TP), #67513/93
- K860641 — EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
- K860918 — EASY-TEST AMLASE (AMYL), #67521/93
- K855079 — NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
- K860135 — EASY-TEST UREA (BUN) REAGENT
- K855080 — EMDS GLUCOSE TEST PACK ITEM 67656/95
- K860134 — EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
- K855056 — EMDS TOTAL CK TEST PACK-#67670/95
- K854585 — ULTRAZYME PLUS & SYSTEMATE LDH
- K852481 — UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
- K852482 — MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
- K852483 — SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
- K852066 — PREGNANCY CARD TEST
- K850128 — SYSTE MATE TIBC HEM NO. 67225
- K845020 — SYSTE MATE IRON, HEM NO. 67224
- K843645 — SYSTEMATE A AMYLASE HEM 67204
- K843328 — SYSTEMATE T-BILI 67212
- K843329 — SYSTEMATE D-BILI 67213
- K843333 — SYSTEMATE GOT 67208
- K843334 — SYSTEMATE GPT 67209
- K843326 — SYSTEMATE BUN HEM NO. 67221
- K843327 — SYSTEMATE CHOLESTEROL 67222
- K843330 — SYSTEMATE PHOSPHORUS 67217
- K843268 — SYSTEMATE 2GT - 67207
- K843269 — SYSTEMATE LDH, 67210
- K843270 — SYSTEMATE ALKALINE PHOSPHATASE-67203
- K843325 — SYSTEMATE URIC ACID, HEM 67220
- K843271 — SYSTEMATE CK-TOTAL - 67206
- K843152 — SYSTEMATE CALCIUM 67214
- K843105 — SYSTEMATE CREATININE 67223
- K843106 — SYSTEMATE TRIGLYCERIDE 67219
- K843107 — SYSTEMATE TOTAL PROTEIN 67218
- K843108 — SYSTEMATE ALBUMIN
- K843150 — SYSTEMATE GLUCOSE 67216
- K843151 — SYSTEMATE GLUCOSE 67215
- K842211 — ULTRA CHEM ENZYMATIC TRIGLYCERIDE
- K841471 — ULTRA CHEM ENZYMATIC TRIGLYCERIDE
Data sourced from openFDA. This site is unofficial and independent of the FDA.