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FDA 510(k)

FISHER DIAGNOSTICS KDA CALIBRATOR II

K-Number: K851151 · 1985-05-20

ApplicantFisher Scientific Co., LLC
Decision Date1985-05-20
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FISHER DIAGNOSTICS KDA CALIBRATOR II is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1985-05-20 under 510(k) number K851151. 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 FISHER DIAGNOSTICS KDA CALIBRATOR II?

FISHER DIAGNOSTICS KDA CALIBRATOR II is a medical device that received FDA 510(k) clearance on 1985-05-20. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K851151.

When did FISHER DIAGNOSTICS KDA CALIBRATOR II receive FDA 510(k) clearance?

FISHER DIAGNOSTICS KDA CALIBRATOR II received FDA 510(k) clearance on 1985-05-20, under 510(k) number K851151.

Who is the listed applicant for FISHER DIAGNOSTICS KDA CALIBRATOR II?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FISHER DIAGNOSTICS KDA CALIBRATOR II?

The FDA product code for FISHER DIAGNOSTICS KDA CALIBRATOR II is JIX.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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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