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Em Diagnostic Systems, Inc.

288 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX (K870553)Em Diagnostic Systems, Inc.1987-03-06
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608 (K870408)Em Diagnostic Systems, Inc.1987-03-04
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 (K870571)Em Diagnostic Systems, Inc.1987-03-04
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 (K870407)Em Diagnostic Systems, Inc.1987-03-04
IRON(IRN) TESTPACK, ITEM NO. 67659/95 (K870144)Em Diagnostic Systems, Inc.1987-02-20
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 (K870143)Em Diagnostic Systems, Inc.1987-02-11
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93 (K870247)Em Diagnostic Systems, Inc.1987-02-11
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 (K864894)Em Diagnostic Systems, Inc.1987-01-09
EASY-TEST QUINIDINE ITEM NO. 67---/95 (K864607)Em Diagnostic Systems, Inc.1987-01-08
EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 (K864553)Em Diagnostic Systems, Inc.1987-01-08
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95 (K864926)Em Diagnostic Systems, Inc.1987-01-07
EASY-TEST PRIMIDONE ITEM NO. 67---/95 (K864554)Em Diagnostic Systems, Inc.1987-01-07
EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95 (K864925)Em Diagnostic Systems, Inc.1987-01-07
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93 (K864715)Em Diagnostic Systems, Inc.1986-12-31
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 (K863963)Em Diagnostic Systems, Inc.1986-11-28
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95 (K863962)Em Diagnostic Systems, Inc.1986-11-28
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 (K864041)Em Diagnostic Systems, Inc.1986-11-25
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95 (K863738)Em Diagnostic Systems, Inc.1986-11-05
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95 (K863660)Em Diagnostic Systems, Inc.1986-10-29
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95 (K863718)Em Diagnostic Systems, Inc.1986-10-29
CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 (K863478)Em Diagnostic Systems, Inc.1986-10-29
EMDS(TM) ALCOHOL TESTPACKS, #67691/95 (K863419)Em Diagnostic Systems, Inc.1986-09-29
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95 (K863544)Em Diagnostic Systems, Inc.1986-09-29
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 (K863477)Em Diagnostic Systems, Inc.1986-09-26
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 (K863545)Em Diagnostic Systems, Inc.1986-09-25
EMDS(TM) ALBUMIN TESTPACKS, #67652/95 (K863004)Em Diagnostic Systems, Inc.1986-09-16
EMDS(TM) CALCIUM TESTPACKS, #67687/95 (K863003)Em Diagnostic Systems, Inc.1986-09-16
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95 (K863005)Em Diagnostic Systems, Inc.1986-08-29
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95 (K862845)Em Diagnostic Systems, Inc.1986-08-29
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT) (K863094)Em Diagnostic Systems, Inc.1986-08-29
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93 (K862453)Em Diagnostic Systems, Inc.1986-08-19
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95 (K862525)Em Diagnostic Systems, Inc.1986-08-19
EMDS(TM) MAGNESIUM TESTPACKS, #67671/95 (K863002)Em Diagnostic Systems, Inc.1986-08-19
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95 (K862707)Em Diagnostic Systems, Inc.1986-08-19
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 (K862704)Em Diagnostic Systems, Inc.1986-08-19
EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95 (K862706)Em Diagnostic Systems, Inc.1986-08-19
EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95 (K862703)Em Diagnostic Systems, Inc.1986-08-04
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 (K862350)Em Diagnostic Systems, Inc.1986-07-07
EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93 (K862308)Em Diagnostic Systems, Inc.1986-07-07
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93 (K862349)Em Diagnostic Systems, Inc.1986-07-07
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 (K861512)Em Diagnostic Systems, Inc.1986-05-23
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 (K860935)Em Diagnostic Systems, Inc.1986-05-23
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK (K861061)Em Diagnostic Systems, Inc.1986-04-24
EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95 (K861055)Em Diagnostic Systems, Inc.1986-04-24
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST (K861221)Em Diagnostic Systems, Inc.1986-04-24
EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93 (K860640)Em Diagnostic Systems, Inc.1986-04-09
EASY-TEST URIC ACID (URIC), #67516/93 (K860916)Em Diagnostic Systems, Inc.1986-04-07
EASY-TEST TOTAL PROTEIN (TP), #67513/93 (K860917)Em Diagnostic Systems, Inc.1986-04-07
ION-SPECIFIC ELECTRODE, CHLORIDE (K860668)Em Diagnostic Systems, Inc.1986-04-07
CREATINE KINASE, N-ACETYL-L-CYSTIENE (K860669)Em Diagnostic Systems, Inc.1986-04-07
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II (K860765)Em Diagnostic Systems, Inc.1986-04-07
EMDS ENZYME VERIFIER, LEVELS I & II (K860764)Em Diagnostic Systems, Inc.1986-04-07
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 (K860641)Em Diagnostic Systems, Inc.1986-04-03
EASY-TEST AMLASE (AMYL), #67521/93 (K860918)Em Diagnostic Systems, Inc.1986-04-03
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 (K855079)Em Diagnostic Systems, Inc.1986-03-05
EASY-TEST UREA (BUN) REAGENT (K860135)Em Diagnostic Systems, Inc.1986-02-21
EMDS GLUCOSE TEST PACK ITEM 67656/95 (K855080)Em Diagnostic Systems, Inc.1986-02-11
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT (K860134)Em Diagnostic Systems, Inc.1986-02-06
EMDS TOTAL CK TEST PACK-#67670/95 (K855056)Em Diagnostic Systems, Inc.1986-01-22
ULTRAZYME PLUS & SYSTEMATE LDH (K854585)Em Diagnostic Systems, Inc.1985-12-05
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM (K852481)Em Diagnostic Systems, Inc.1985-08-21
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 (K852482)Em Diagnostic Systems, Inc.1985-07-15
SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 (K852483)Em Diagnostic Systems, Inc.1985-07-12
PREGNANCY CARD TEST (K852066)Em Diagnostic Systems, Inc.1985-06-25
SYSTE MATE TIBC HEM NO. 67225 (K850128)Em Diagnostic Systems, Inc.1985-02-01
SYSTE MATE IRON, HEM NO. 67224 (K845020)Em Diagnostic Systems, Inc.1985-01-28
SYSTEMATE A AMYLASE HEM 67204 (K843645)Em Diagnostic Systems, Inc.1984-09-28
SYSTEMATE GOT 67208 (K843333)Em Diagnostic Systems, Inc.1984-09-20
SYSTEMATE D-BILI 67213 (K843329)Em Diagnostic Systems, Inc.1984-09-20
SYSTEMATE T-BILI 67212 (K843328)Em Diagnostic Systems, Inc.1984-09-20
SYSTEMATE GPT 67209 (K843334)Em Diagnostic Systems, Inc.1984-09-20
SYSTEMATE CHOLESTEROL 67222 (K843327)Em Diagnostic Systems, Inc.1984-09-14
SYSTEMATE BUN HEM NO. 67221 (K843326)Em Diagnostic Systems, Inc.1984-09-14
SYSTEMATE PHOSPHORUS 67217 (K843330)Em Diagnostic Systems, Inc.1984-09-14
SYSTEMATE 2GT - 67207 (K843268)Em Diagnostic Systems, Inc.1984-09-13
SYSTEMATE ALKALINE PHOSPHATASE-67203 (K843270)Em Diagnostic Systems, Inc.1984-09-13
SYSTEMATE URIC ACID, HEM 67220 (K843325)Em Diagnostic Systems, Inc.1984-09-13
SYSTEMATE LDH, 67210 (K843269)Em Diagnostic Systems, Inc.1984-09-13
SYSTEMATE CK-TOTAL - 67206 (K843271)Em Diagnostic Systems, Inc.1984-09-07
SYSTEMATE CALCIUM 67214 (K843152)Em Diagnostic Systems, Inc.1984-08-29
SYSTEMATE GLUCOSE 67216 (K843150)Em Diagnostic Systems, Inc.1984-08-27
SYSTEMATE ALBUMIN (K843108)Em Diagnostic Systems, Inc.1984-08-27
SYSTEMATE TOTAL PROTEIN 67218 (K843107)Em Diagnostic Systems, Inc.1984-08-27
SYSTEMATE CREATININE 67223 (K843105)Em Diagnostic Systems, Inc.1984-08-27
SYSTEMATE GLUCOSE 67215 (K843151)Em Diagnostic Systems, Inc.1984-08-27
SYSTEMATE TRIGLYCERIDE 67219 (K843106)Em Diagnostic Systems, Inc.1984-08-27
ULTRA CHEM ENZYMATIC TRIGLYCERIDE (K842211)Em Diagnostic Systems, Inc.1984-07-06
ULTRA CHEM ENZYMATIC TRIGLYCERIDE (K841471)Em Diagnostic Systems, Inc.1984-05-16
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