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FDA 510(k)

IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA

K-Number: K812488 · 1981-09-23

ApplicantDako Corp.
Decision Date1981-09-23
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812488. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA?

IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Dako Corp.. The 510(k) number is K812488.

When did IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA receive FDA 510(k) clearance?

IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812488.

Who is the listed applicant for IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA?

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 IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA?

The FDA product code for IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA is CZP.

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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: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott 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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