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FDA 510(k)

ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER

K-Number: K942753 · 1994-11-02

ApplicantResearched, Novel Medical Devices (Rn/Md)
Decision Date1994-11-02
Product CodeEYZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Researched, Novel Medical Devices (Rn/Md). It received FDA 510(k) clearance on 1994-11-02 under 510(k) number K942753. The device is classified under product code EYZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER?

ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER is a medical device that received FDA 510(k) clearance on 1994-11-02. The listed applicant is Researched, Novel Medical Devices (Rn/Md). The 510(k) number is K942753.

When did ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER receive FDA 510(k) clearance?

ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER received FDA 510(k) clearance on 1994-11-02, under 510(k) number K942753.

Who is the listed applicant for ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER?

The FDA 510(k) record lists Researched, Novel Medical Devices (Rn/Md) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER?

The FDA product code for ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER is EYZ.

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.

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Other records listing Researched, Novel Medical Devices (Rn/Md) 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.

K944680SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICEK925234BEDSIDE CADDY

Related Devices (Code: EYZ)

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.

K964219ZIP CONDOM CATHETERGoulter Medical, Inc.K961906UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018Spectrum Medsystems Corp.K952780URINARY GEL DRAINAGE SYSTEMP.A.M., Inc.K951597URINARY DRAINAGE BAGKey Medical Services, Inc.K933126COMFORTCARE SYSTEMPatsy J. Trisler, J.D.K930556NIGHT URINARY DRAINAGE BEDSIDE BAGEzmt Valve Co., 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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