FDA 510(k)

DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR

K-Number: K993957 · 2000-03-03

Decision Date2000-03-03

Product CodeMYA

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 2000-03-03 under 510(k) number K993957. The device is classified under product code MYA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR?

DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR is a medical device that received FDA 510(k) clearance on 2000-03-03. The listed applicant is Dako Corp.. The 510(k) number is K993957.

When did DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR receive FDA 510(k) clearance?

DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR received FDA 510(k) clearance on 2000-03-03, under 510(k) number K993957.

Who is the listed applicant for DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR?

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 MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR?

The FDA product code for DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR is MYA.

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Other records listing Dako Corp. as applicant

K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING K991454MOUSE IGG1 NEGATIVE CONTROLS K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 K971905DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING K965022MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)

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Related Devices (Code: MYA)

K183100Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, NovocastraLeica Biosystems Newcastle, Limited K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)Dako Denmark A/S K120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIDako North America, Inc.K110215CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODYVentana Medical Systems, Inc.K081286MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634Dako North America, Inc.K061360NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)Lab Vision Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.