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FDA 510(k)

SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477

K-Number: K910638 · 1991-03-11

ApplicantEm Diagnostic Systems, Inc.
Decision Date1991-03-11
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-03-11 under 510(k) number K910638. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477?

SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 is a medical device that received FDA 510(k) clearance on 1991-03-11. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K910638.

When did SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 receive FDA 510(k) clearance?

SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 received FDA 510(k) clearance on 1991-03-11, under 510(k) number K910638.

Who is the listed applicant for SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477?

The FDA 510(k) record lists Em Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477?

The FDA product code for SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 is CDT.

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Other records listing Em Diagnostic Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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Related Devices (Code: CDT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.K113830VANTERA CLINICAL ANALYZERLiposcienceK102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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