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FDA 510(k)

ROCHE STANDARDS FOR THE COBAS ISE MODULE

K-Number: K897071 · 1990-03-09

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-03-09
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE STANDARDS FOR THE COBAS ISE MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-03-09 under 510(k) number K897071. 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 ROCHE STANDARDS FOR THE COBAS ISE MODULE?

ROCHE STANDARDS FOR THE COBAS ISE MODULE is a medical device that received FDA 510(k) clearance on 1990-03-09. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K897071.

When did ROCHE STANDARDS FOR THE COBAS ISE MODULE receive FDA 510(k) clearance?

ROCHE STANDARDS FOR THE COBAS ISE MODULE received FDA 510(k) clearance on 1990-03-09, under 510(k) number K897071.

Who is the listed applicant for ROCHE STANDARDS FOR THE COBAS ISE MODULE?

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

What is the FDA product code for ROCHE STANDARDS FOR THE COBAS ISE MODULE?

The FDA product code for ROCHE STANDARDS FOR THE COBAS ISE MODULE is JIX.

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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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