FDA 510(k)

CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE

K-Number: K897177 · 1990-03-27

Decision Date1990-03-27

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corp.. It received FDA 510(k) clearance on 1990-03-27 under 510(k) number K897177. 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 CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE?

CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE is a medical device that received FDA 510(k) clearance on 1990-03-27. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K897177.

When did CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE receive FDA 510(k) clearance?

CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE received FDA 510(k) clearance on 1990-03-27, under 510(k) number K897177.

Who is the listed applicant for CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE?

The FDA 510(k) record lists Nova Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE?

The FDA product code for CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE is JIX.

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Other records listing Nova Biomedical Corp. as applicant

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Related Devices (Code: JIX)

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 Diagnostics K130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroup K123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare Diagnostics K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott Laboratories K122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

Official Source

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