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 PHENOBARBITAL

K-Number: K852995 · 1985-08-12

ApplicantImmunotech Corp.
Decision Date1985-08-12
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ENDAB PHENOBARBITAL is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech Corp.. It received FDA 510(k) clearance on 1985-08-12 under 510(k) number K852995. The device is classified under product code DLZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDAB PHENOBARBITAL?

ENDAB PHENOBARBITAL is a medical device that received FDA 510(k) clearance on 1985-08-12. The listed applicant is Immunotech Corp.. The 510(k) number is K852995.

When did ENDAB PHENOBARBITAL receive FDA 510(k) clearance?

ENDAB PHENOBARBITAL received FDA 510(k) clearance on 1985-08-12, under 510(k) number K852995.

Who is the listed applicant for ENDAB PHENOBARBITAL?

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 PHENOBARBITAL?

The FDA product code for ENDAB PHENOBARBITAL is DLZ.

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: DLZ)

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.

K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.K123271ABBOTT PHENOBARBITAL ASSAYMicrogenics Corp.K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33Abbott LaboratoriesK071644ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620Roche Diagnostics Corp.K011303RANDOX PHENOBARBITALRandox Laboratories, Ltd.K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229Syva Co.

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.

↑