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)

EPISCREEN

K-Number: K970357 · 1997-03-10

ApplicantEpitope, Inc.
Decision Date1997-03-10
Product CodePJD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EPISCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Epitope, Inc.. It received FDA 510(k) clearance on 1997-03-10 under 510(k) number K970357. The device is classified under product code PJD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPISCREEN?

EPISCREEN is a medical device that received FDA 510(k) clearance on 1997-03-10. The listed applicant is Epitope, Inc.. The 510(k) number is K970357.

When did EPISCREEN receive FDA 510(k) clearance?

EPISCREEN received FDA 510(k) clearance on 1997-03-10, under 510(k) number K970357.

Who is the listed applicant for EPISCREEN?

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

What is the FDA product code for EPISCREEN?

The FDA product code for EPISCREEN is PJD.

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 Epitope, Inc. 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.

K973395EPISCREEN ORAL SPECIMEN COLLECTION DEVICE

Related Devices (Code: PJD)

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.

K232898Quantisal™ Oral Fluid Collection DeviceImmunalysis CorporationK223781Quantisal™ II Oral Fluid Collection DeviceImmunalysis CorporationK200801Quantisal Oral Fluid Collection DeviceImmunalysis CorporationK183048Quantisal II Oral Fluid Collection DeviceImmunalysis CorporationK011057INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXXOraSure Technologies, Inc.K984361ORAL-EZE ORAL FLUID COLLECTION SYSTEMOsborn Laboratories, 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.

↑