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FDA 510(k)

DAKO ITA, IMMUNOGLOBULIN M (IGM)

K-Number: K862184 · 1986-08-19

ApplicantDako Corp.
Decision Date1986-08-19
Product CodeDAH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DAKO ITA, IMMUNOGLOBULIN M (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 1986-08-19 under 510(k) number K862184. The device is classified under product code DAH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAKO ITA, IMMUNOGLOBULIN M (IGM)?

DAKO ITA, IMMUNOGLOBULIN M (IGM) is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Dako Corp.. The 510(k) number is K862184.

When did DAKO ITA, IMMUNOGLOBULIN M (IGM) receive FDA 510(k) clearance?

DAKO ITA, IMMUNOGLOBULIN M (IGM) received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862184.

Who is the listed applicant for DAKO ITA, IMMUNOGLOBULIN M (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 DAKO ITA, IMMUNOGLOBULIN M (IGM)?

The FDA product code for DAKO ITA, IMMUNOGLOBULIN M (IGM) is DAH.

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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: DAH)

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.

K931247TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067Helena LaboratoriesK905149TITAN GELHelena LaboratoriesK901805REP(R) IMMUNOFIXHelena LaboratoriesK884074IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN GOrion Diagnostica, Inc.K883494TECHNICON DPA-1 IMMUNOGLOBULIN GTechnicon Instruments Corp.K854944TDX IMMUNOGLOBULIN M DIAGNOSTIC KITAbbott Laboratories

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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