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FDA 510(k)

URI-DIP (R)

K-Number: K800626 · 1980-04-24

ApplicantPharma-Medica of Scandinavia, Ltd.
Decision Date1980-04-24
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

URI-DIP (R) is the device name listed in this FDA 510(k) record. The listed applicant is Pharma-Medica of Scandinavia, Ltd.. It received FDA 510(k) clearance on 1980-04-24 under 510(k) number K800626. The device is classified under product code JXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URI-DIP (R)?

URI-DIP (R) is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Pharma-Medica of Scandinavia, Ltd.. The 510(k) number is K800626.

When did URI-DIP (R) receive FDA 510(k) clearance?

URI-DIP (R) received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800626.

Who is the listed applicant for URI-DIP (R)?

The FDA 510(k) record lists Pharma-Medica of Scandinavia, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URI-DIP (R)?

The FDA product code for URI-DIP (R) is JXA.

Other records listing Pharma-Medica of Scandinavia, Ltd. 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.

K852987CARIESCREEN - SM

Related Devices (Code: JXA)

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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)OsmetechK981084URISCREENDiatech Diagnostics,Inc.K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.K950246MULTIPLE (IZON URINE COLLECTION KIT)Izon Business Products, 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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