Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN

K-Number: K812492 · 1981-09-23

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

Device Summary

IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN 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 K812492. The device is classified under product code DDG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN 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 K812492.

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

IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812492.

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

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.-TRAN?

The FDA product code for IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN is DDG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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: DDG)

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.

K240987Access sTfRBeckman Coulter, Inc.K190495TransferrinBiosystems S.A.K182095Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo)K120236TRANSFERRIN KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.K080634ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495Beckman Coulter, Inc.K081299DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTASiemens Healthcare 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.

↑