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)

ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT

K-Number: K803296 · 1981-01-16

ApplicantImmunotech Corp.
Decision Date1981-01-16
Product CodeKWW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech Corp.. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K803296. The device is classified under product code KWW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT?

ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Immunotech Corp.. The 510(k) number is K803296.

When did ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT receive FDA 510(k) clearance?

ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT received FDA 510(k) clearance on 1981-01-16, under 510(k) number K803296.

Who is the listed applicant for ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT?

The FDA 510(k) record lists Immunotech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT?

The FDA product code for ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT is KWW.

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 Immunotech 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.

K954188OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROLK952789OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIESK950626OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIESK931228PROGESTERONE RADIOIMMUNOASSAY KITK911634MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TESTK911153MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT

View all 37 devices →

Related Devices (Code: KWW)

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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITCatachem, Inc.K051714TOTAL BILE ACIDS ASSAY, MODEL DZ042ADiazyme LaboratoriesK970120BILE ACIDS REAGENT SETTeco DiagnosticsK872296BILE ACIDS REAGENTSigma Diagnostics, Inc.K781337CONJUGATED BILE ACIDS RIA KITBd Becton Dickinson Vacutainer Systems Preanalytic

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.

↑