510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Em Diagnostic Systems, Inc.

Walker, MI, US

Em Diagnostic Systems, Inc. appears in FDA device records in Walker, MI. FDA records list 288 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
288
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 288

FDA records hold 288 510(k) clearances for Em Diagnostic Systems, Inc. between 1984 and 1994. The busiest year on record is 1987, with 49. The most recent is 1994, with 2.

Clearances by year, as a table
510(k) clearance decisions for Em Diagnostic Systems, Inc., by decision year
YearClearances
198422
19857
198646
198749
198816
198945
199016
199134
199223
199328
19942
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K935181ASPARTATE AMINOTRANSFERASE (AST) TESTCITSubstantially Equivalent
K935180ALANINE AMINOTRANSFERASE (ALT) TESTCKASubstantially Equivalent
K935179EMDS ALBUMIN (ALB) TESTCIXSubstantially Equivalent
K935178EMDS PHOSPHOROUS (PHOS) TESTCEOSubstantially Equivalent
K935177GAMMA-GLUTAMYL TRANSFERASE (GGT) TESTJQBSubstantially Equivalent
K935176IRON TESTJIYSubstantially Equivalent
K935175LACTATE DEHYDROGENASE (LD)CFJSubstantially Equivalent
K935174TOTAL PROTEIN TEST (TPRO)CEKSubstantially Equivalent
K935136CHOLESTEROL (CHOL) TEST ITEM NO. 65410CHHSubstantially Equivalent
K935183EMDS MAGNESIUM (MG) TESTJGJSubstantially Equivalent
K935182EMDS ALKANINE PHOSPHATASE (ALP) TESTCJESubstantially Equivalent
K932162URIC ACID TEST ITEM NUMBER 65422CDOSubstantially Equivalent
K932158CALCIUM TEST ITEM NUMBER 65409CICSubstantially Equivalent
K932159SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406CIGSubstantially Equivalent
K932161UREA NITROGEN TEST ITEM NUMBER 65408CDQSubstantially Equivalent
K931891TRIGLYCERIDESCDTSubstantially Equivalent
K931583SILYL AMYLJFJSubstantially Equivalent
K931582ETHYLIDENE AMYLJFJSubstantially Equivalent
K931887BICARBONATEKHSSubstantially Equivalent
K931889CREATINE KINASE TESTCGSSubstantially Equivalent
K931888TOTAL BILIRUBINCIGSubstantially Equivalent
K931890GLUCOSE-HK TESTCFRSubstantially Equivalent
K932160SYSTEMATE CREATININE TEST ITEM NUMBER 65413CGXSubstantially Equivalent
K930166IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/RJIYSubstantially Equivalent
K925101SYSTEMATE PLUS CALIBRATORJIXSubstantially Equivalent
K925188ABBOTT QUICKSTART LD-1, MODIFICATIONJGFSubstantially Equivalent
K924703LACTATE DEHYDROGENASE (LD) TEST ITEM #65418CFJSubstantially Equivalent
K924508CHOLESTEROL TEST ITEM# 42374/93, 42322/R1CHHSubstantially Equivalent
K924710TRIGLYCERIDESCDTSubstantially Equivalent
K925002UREA NITROGEN TESTCDQSubstantially Equivalent
K923959ALBUMIN TESTCIXSubstantially Equivalent
K924711BICARBONATEKHSSubstantially Equivalent
K924572EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415CFRSubstantially Equivalent
K924574EMDS ALKALINE PHOSPHATASE (ALP) TESTCJESubstantially Equivalent
K924573SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TESTCDTSubstantially Equivalent
K923733CHOLESTEROL TESTCHHSubstantially Equivalent
K924599CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2CGXSubstantially Equivalent
K924470TWO PART INORGANIC PHOSPHORUS TESTCEOSubstantially Equivalent
K924704CREATINE KINASE (CK) TEST ITEM #65411CGSSubstantially Equivalent
K923257EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000CKASubstantially Equivalent
K922947GAMMA GULTAMYL TRANSFERASE TESTJQBSubstantially Equivalent
K923765SYSTEMATE URICACID TEST, TECHNICON RA 1000CDOSubstantially Equivalent
K923764SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000CEOSubstantially Equivalent
K923677AMYLASE TESTJFJSubstantially Equivalent
K923267SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000CEKSubstantially Equivalent
K923203SYSTEMATE CREATININE TESTCGXSubstantially Equivalent
K923083TOTAL BILIRUBIN CATALOG NO. 65407CIGSubstantially Equivalent
K922953SYSTEMATE CALCIUM TEST TECHNICON RA 1000CILSubstantially Equivalent
K922857SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICOCITSubstantially Equivalent
K922856SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000CIGSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain