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FDA 510(k)

SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420

K-Number: K905661 · 1991-01-31

ApplicantEm Diagnostic Systems, Inc.
Decision Date1991-01-31
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 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 1991-01-31 under 510(k) number K905661. The device is classified under product code CEK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420?

SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 is a medical device that received FDA 510(k) clearance on 1991-01-31. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K905661.

When did SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 receive FDA 510(k) clearance?

SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 received FDA 510(k) clearance on 1991-01-31, under 510(k) number K905661.

Who is the listed applicant for SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420?

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 TOTAL PROTEIN (EPOS APPLICATION) #65420?

The FDA product code for SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 is CEK.

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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: CEK)

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.

K992846HICHEM TOTAL PROTEIN REAGENTElan Holdings, Inc.K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50Diagnostic Chemicals , Ltd.K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,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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