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FDA 510(k)

FLUORESCEIN CONJUGATED IMMUNOGLOBIN-

K-Number: K831902 · 1983-07-18

ApplicantDako Corp.
Decision Date1983-07-18
Product CodeDDZ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLUORESCEIN CONJUGATED IMMUNOGLOBIN- is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1983-07-18 under 510(k) number K831902. The device is classified under product code DDZ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORESCEIN CONJUGATED IMMUNOGLOBIN-?

FLUORESCEIN CONJUGATED IMMUNOGLOBIN- is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Dako Corp.. The 510(k) number is K831902.

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

FLUORESCEIN CONJUGATED IMMUNOGLOBIN- received FDA 510(k) clearance on 1983-07-18, under 510(k) number K831902.

Who is the listed applicant for FLUORESCEIN CONJUGATED IMMUNOGLOBIN-?

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 IMMUNOGLOBIN-?

The FDA product code for FLUORESCEIN CONJUGATED IMMUNOGLOBIN- is DDZ.

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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: DDZ)

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.

K050576MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-HGood Biotech Corp.K023860MICROALBUMIN REAGENT SET AND CALIBRATORSPointe Scientific, Inc.,K002674RANDOX MICROALBUMINRandox Laboratories, 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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