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FDA 510(k)

DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY

K-Number: K871346 · 1987-04-21

ApplicantDako Corp.
Decision Date1987-04-21
Product CodeCZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1987-04-21 under 510(k) number K871346. The device is classified under product code CZW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY?

DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1987-04-21. The listed applicant is Dako Corp.. The 510(k) number is K871346.

When did DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY receive FDA 510(k) clearance?

DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY received FDA 510(k) clearance on 1987-04-21, under 510(k) number K871346.

Who is the listed applicant for DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY?

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

What is the FDA product code for DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY?

The FDA product code for DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY is CZW.

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Other records listing Dako Corp. 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.

K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGK993957DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTORK991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1K991454MOUSE IGG1 NEGATIVE CONTROLSK980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37K971905DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING

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Related Devices (Code: CZW)

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.

K100179SPAPLUSThe Binding Site Group , Ltd.K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLThermo Electron OYK061852DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.K050665N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)Dade Behring, Inc.K042494VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIIOrtho-Clinical DiagnosticsK032796IBL C3D-CIC EIA TESTIbl GmbH

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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