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FDA 510(k)

MOUSE IGG1 NEGATIVE CONTROLS

K-Number: K991454 · 1999-06-21

ApplicantDako Corp.
Decision Date1999-06-21
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MOUSE IGG1 NEGATIVE CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1999-06-21 under 510(k) number K991454. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUSE IGG1 NEGATIVE CONTROLS?

MOUSE IGG1 NEGATIVE CONTROLS is a medical device that received FDA 510(k) clearance on 1999-06-21. The listed applicant is Dako Corp.. The 510(k) number is K991454.

When did MOUSE IGG1 NEGATIVE CONTROLS receive FDA 510(k) clearance?

MOUSE IGG1 NEGATIVE CONTROLS received FDA 510(k) clearance on 1999-06-21, under 510(k) number K991454.

Who is the listed applicant for MOUSE IGG1 NEGATIVE CONTROLS?

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 MOUSE IGG1 NEGATIVE CONTROLS?

The FDA product code for MOUSE IGG1 NEGATIVE CONTROLS is GKZ.

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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 UCHT1K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37K971905DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAININGK965022MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)

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Related Devices (Code: GKZ)

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.

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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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