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FDA 510(k)

COBAS CALIBRATOR SERUM

K-Number: K850859 · 1985-05-10

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-05-10
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS CALIBRATOR SERUM 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 1985-05-10 under 510(k) number K850859. 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 COBAS CALIBRATOR SERUM?

COBAS CALIBRATOR SERUM is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K850859.

When did COBAS CALIBRATOR SERUM receive FDA 510(k) clearance?

COBAS CALIBRATOR SERUM received FDA 510(k) clearance on 1985-05-10, under 510(k) number K850859.

Who is the listed applicant for COBAS CALIBRATOR SERUM?

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 COBAS CALIBRATOR SERUM?

The FDA product code for COBAS CALIBRATOR SERUM is JIX.

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Other records listing Roche 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.

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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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