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FDA 510(k)

FLUORESCEIN CONJUGATED IMMUNOGLOBULIN

K-Number: K831903 · 1983-07-19

ApplicantDako Corp.
Decision Date1983-07-19
Product CodeDES
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLUORESCEIN CONJUGATED IMMUNOGLOBULIN is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831903. The device is classified under product code DES. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORESCEIN CONJUGATED IMMUNOGLOBULIN?

FLUORESCEIN CONJUGATED IMMUNOGLOBULIN is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Dako Corp.. The 510(k) number is K831903.

When did FLUORESCEIN CONJUGATED IMMUNOGLOBULIN receive FDA 510(k) clearance?

FLUORESCEIN CONJUGATED IMMUNOGLOBULIN received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831903.

Who is the listed applicant for FLUORESCEIN CONJUGATED IMMUNOGLOBULIN?

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 FLUORESCEIN CONJUGATED IMMUNOGLOBULIN?

The FDA product code for FLUORESCEIN CONJUGATED IMMUNOGLOBULIN is DES.

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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

View all 54 devices →

Related Devices (Code: DES)

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.

K832267FITC GOAT ANTI-HUMAN LAMBAGelco Diagnostics, 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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