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FDA 510(k)

DAKO PAP KIT K509

K-Number: K820336 · 1982-07-13

ApplicantDako Corp.
Decision Date1982-07-13
Product CodeLIJ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

DAKO PAP KIT K509 is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1982-07-13 under 510(k) number K820336. The device is classified under product code LIJ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAKO PAP KIT K509?

DAKO PAP KIT K509 is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Dako Corp.. The 510(k) number is K820336.

When did DAKO PAP KIT K509 receive FDA 510(k) clearance?

DAKO PAP KIT K509 received FDA 510(k) clearance on 1982-07-13, under 510(k) number K820336.

Who is the listed applicant for DAKO PAP KIT K509?

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 PAP KIT K509?

The FDA product code for DAKO PAP KIT K509 is LIJ.

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: LIJ)

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.

K855034AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANTBartels Immunodiagnostic Supplies, 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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