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FDA 510(k)

CHANGES IN THE CHEMICAL COMP. OF 5

K-Number: K841464 · 1984-06-22

ApplicantNova Biomedical Corp.
Decision Date1984-06-22
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHANGES IN THE CHEMICAL COMP. OF 5 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 1984-06-22 under 510(k) number K841464. 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 CHANGES IN THE CHEMICAL COMP. OF 5?

CHANGES IN THE CHEMICAL COMP. OF 5 is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K841464.

When did CHANGES IN THE CHEMICAL COMP. OF 5 receive FDA 510(k) clearance?

CHANGES IN THE CHEMICAL COMP. OF 5 received FDA 510(k) clearance on 1984-06-22, under 510(k) number K841464.

Who is the listed applicant for CHANGES IN THE CHEMICAL COMP. OF 5?

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 CHANGES IN THE CHEMICAL COMP. OF 5?

The FDA product code for CHANGES IN THE CHEMICAL COMP. OF 5 is JIX.

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Other records listing Nova Biomedical Corp. as applicant

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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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