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FDA 510(k)

ORAL-EZE ORAL FLUID COLLECTION SYSTEM

K-Number: K984361 · 1999-01-13

ApplicantOsborn Laboratories, Inc.
Decision Date1999-01-13
Product CodePJD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ORAL-EZE ORAL FLUID COLLECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osborn Laboratories, Inc.. It received FDA 510(k) clearance on 1999-01-13 under 510(k) number K984361. 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 ORAL-EZE ORAL FLUID COLLECTION SYSTEM?

ORAL-EZE ORAL FLUID COLLECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-13. The listed applicant is Osborn Laboratories, Inc.. The 510(k) number is K984361.

When did ORAL-EZE ORAL FLUID COLLECTION SYSTEM receive FDA 510(k) clearance?

ORAL-EZE ORAL FLUID COLLECTION SYSTEM received FDA 510(k) clearance on 1999-01-13, under 510(k) number K984361.

Who is the listed applicant for ORAL-EZE ORAL FLUID COLLECTION SYSTEM?

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

What is the FDA product code for ORAL-EZE ORAL FLUID COLLECTION SYSTEM?

The FDA product code for ORAL-EZE ORAL FLUID COLLECTION SYSTEM is PJD.

Related Clinical Trials

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Other records listing Osborn Laboratories, 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.

K984529HEMOCHEK SAMPLE COLLECTION KIT

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.K973395EPISCREEN ORAL SPECIMEN COLLECTION DEVICEEpitope, 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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