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FDA 510(k)

URINE SAMPLE COLLECTION KIT

K-Number: K780057 · 1978-02-21

ApplicantC.R. Bard, Inc.
Decision Date1978-02-21
Product CodeFMH
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

URINE SAMPLE COLLECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1978-02-21 under 510(k) number K780057. The device is classified under product code FMH. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE SAMPLE COLLECTION KIT?

URINE SAMPLE COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1978-02-21. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K780057.

When did URINE SAMPLE COLLECTION KIT receive FDA 510(k) clearance?

URINE SAMPLE COLLECTION KIT received FDA 510(k) clearance on 1978-02-21, under 510(k) number K780057.

Who is the listed applicant for URINE SAMPLE COLLECTION KIT?

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

What is the FDA product code for URINE SAMPLE COLLECTION KIT?

The FDA product code for URINE SAMPLE COLLECTION KIT is FMH.

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Related Devices (Code: FMH)

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.

K900983TRI-TECH URINE SPECIMEN KITTri-Tech, Inc.K823763VARIOUS-SPECIMEN COLLECTORSCordis Corp.K820180CALCULI FILTER CUPOmnimedicalK812933LANCER SPECIMEN CONTAINERSherwood Medical Co.K802340SPECIMEN SETAmerican Pharmaseal Div. AhscK802002URINE SPECIMEN CONTAINER #'S 1013-1016Pollak (Intl.), Ltd.

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.

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