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FDA 510(k)

EPISCREEN ORAL SPECIMEN COLLECTION DEVICE

K-Number: K973395 · 1998-02-13

ApplicantEpitope, Inc.
Decision Date1998-02-13
Product CodePJD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EPISCREEN ORAL SPECIMEN COLLECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Epitope, Inc.. It received FDA 510(k) clearance on 1998-02-13 under 510(k) number K973395. 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 ORAL SPECIMEN COLLECTION DEVICE?

EPISCREEN ORAL SPECIMEN COLLECTION DEVICE is a medical device that received FDA 510(k) clearance on 1998-02-13. The listed applicant is Epitope, Inc.. The 510(k) number is K973395.

When did EPISCREEN ORAL SPECIMEN COLLECTION DEVICE receive FDA 510(k) clearance?

EPISCREEN ORAL SPECIMEN COLLECTION DEVICE received FDA 510(k) clearance on 1998-02-13, under 510(k) number K973395.

Who is the listed applicant for EPISCREEN ORAL SPECIMEN COLLECTION DEVICE?

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 ORAL SPECIMEN COLLECTION DEVICE?

The FDA product code for EPISCREEN ORAL SPECIMEN COLLECTION DEVICE 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.

K970357EPISCREEN

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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