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SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 — Em Diagnostic Systems, Inc. (510(k) K852483)

SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 — Em Diagnostic Systems, Inc. (510(k) K852483) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205; Applicant: Em Diagnostic Systems, Inc.; Clearance track: 510(k).

Device nameSYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
ApplicantEm Diagnostic Systems, Inc.
Clearance track510(k)
Submission numberK852483
DecisionSubstantially Equivalent
Decision date1985-07-12
Date received1985-06-11
Product codeCGS
Device class2
Medical specialtyClinical Chemistry
Applicant locationNJ, US
SourceopenFDA device

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