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FDA 510(k)

SYSTEMATE PLUS CALIBRATOR

K-Number: K925101 · 1993-02-23

ApplicantEm Diagnostic Systems, Inc.
Decision Date1993-02-23
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE PLUS CALIBRATOR 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 1993-02-23 under 510(k) number K925101. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMATE PLUS CALIBRATOR?

SYSTEMATE PLUS CALIBRATOR is a medical device that received FDA 510(k) clearance on 1993-02-23. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K925101.

When did SYSTEMATE PLUS CALIBRATOR receive FDA 510(k) clearance?

SYSTEMATE PLUS CALIBRATOR received FDA 510(k) clearance on 1993-02-23, under 510(k) number K925101.

Who is the listed applicant for SYSTEMATE PLUS CALIBRATOR?

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 PLUS CALIBRATOR?

The FDA product code for SYSTEMATE PLUS CALIBRATOR is JIX.

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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: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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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