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)

SPECIMEN COLLECTION DEVICE

K-Number: K780049 · 1978-01-26

ApplicantUrol, Inc.
Decision Date1978-01-26
Product CodeFMH
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

SPECIMEN COLLECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Urol, Inc.. It received FDA 510(k) clearance on 1978-01-26 under 510(k) number K780049. 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 SPECIMEN COLLECTION DEVICE?

SPECIMEN COLLECTION DEVICE is a medical device that received FDA 510(k) clearance on 1978-01-26. The listed applicant is Urol, Inc.. The 510(k) number is K780049.

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

SPECIMEN COLLECTION DEVICE received FDA 510(k) clearance on 1978-01-26, under 510(k) number K780049.

Who is the listed applicant for SPECIMEN COLLECTION DEVICE?

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

What is the FDA product code for SPECIMEN COLLECTION DEVICE?

The FDA product code for SPECIMEN COLLECTION DEVICE is FMH.

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 Urol, 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.

K780974BACILLUS PUMILUS

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.

↑