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FDA 510(k)

DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440

K-Number: K912666 · 1992-02-14

ApplicantDako Corp.
Decision Date1992-02-14
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1992-02-14 under 510(k) number K912666. The device is classified under product code LIQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440?

DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 is a medical device that received FDA 510(k) clearance on 1992-02-14. The listed applicant is Dako Corp.. The 510(k) number is K912666.

When did DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 receive FDA 510(k) clearance?

DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 received FDA 510(k) clearance on 1992-02-14, under 510(k) number K912666.

Who is the listed applicant for DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440?

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 ELISA ROTAVIRUS KIT- 96 TESTS K440?

The FDA product code for DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 is LIQ.

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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: LIQ)

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.

K990842SAS ROTA TESTSa Scientific, Inc.K972895VIDAS ROTAVIRUS (RTV) ASSAYBiomerieux Vitek, Inc.K971585IMMUNOCARD STAT! ROTAVIRUSMeridian Diagnostics, Inc.K964424ROTAVIRUS EIATrinity Biotech, Inc.K965092VIDAS ROTAVIRUS ASSAYBiomerieux Vitek, Inc.K951208ROTA-DAN RAPID ROTAVIRUS EIA KITEldan Technologies, Ltd.

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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