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FDA 510(k)

RABBIT ANTISERUM TO HUMAN IGM

K-Number: K831907 · 1983-07-19

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

Device Summary

RABBIT ANTISERUM TO HUMAN IGM 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 K831907. The device is classified under product code DFS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RABBIT ANTISERUM TO HUMAN IGM?

RABBIT ANTISERUM TO HUMAN IGM 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 K831907.

When did RABBIT ANTISERUM TO HUMAN IGM receive FDA 510(k) clearance?

RABBIT ANTISERUM TO HUMAN IGM received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831907.

Who is the listed applicant for RABBIT ANTISERUM TO HUMAN IGM?

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 RABBIT ANTISERUM TO HUMAN IGM?

The FDA product code for RABBIT ANTISERUM TO HUMAN IGM is DFS.

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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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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.

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