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FDA 510(k)

DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION

K-Number: K951965 · 1996-07-05

ApplicantDako Corp.
Decision Date1996-07-05
Product CodeDEH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1996-07-05 under 510(k) number K951965. The device is classified under product code DEH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION?

DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION is a medical device that received FDA 510(k) clearance on 1996-07-05. The listed applicant is Dako Corp.. The 510(k) number is K951965.

When did DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION receive FDA 510(k) clearance?

DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION received FDA 510(k) clearance on 1996-07-05, under 510(k) number K951965.

Who is the listed applicant for DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION?

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 LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION?

The FDA product code for DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION is DEH.

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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: DEH)

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.

K172471VENTANA CD30 (Ber-H2) RxDx AssayVentana Medical Systems, Inc.K083601LAMBDA LIGHT CHAINSSENTINEL CH. SpAK033811FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZERThe Binding Site, Ltd.K031016FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER IIThe Binding Site, Ltd.K023131FREELITE HUMAN LAMBDA FREE KITThe Binding Site, Ltd.K010440FREELITE LAMBDA FREE KITThe Binding Site, 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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