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FDA 510(k)

URI-THREE(TM), MODIFICATION

K-Number: K911846 · 1991-10-04

ApplicantCulture Kits, Inc.
Decision Date1991-10-04
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

URI-THREE(TM), MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Culture Kits, Inc.. It received FDA 510(k) clearance on 1991-10-04 under 510(k) number K911846. 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-THREE(TM), MODIFICATION?

URI-THREE(TM), MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is Culture Kits, Inc.. The 510(k) number is K911846.

When did URI-THREE(TM), MODIFICATION receive FDA 510(k) clearance?

URI-THREE(TM), MODIFICATION received FDA 510(k) clearance on 1991-10-04, under 510(k) number K911846.

Who is the listed applicant for URI-THREE(TM), MODIFICATION?

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

What is the FDA product code for URI-THREE(TM), MODIFICATION?

The FDA product code for URI-THREE(TM), MODIFICATION is JXA.

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Other records listing Culture Kits, 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.

K854672CANDI-KIT TMK853488STAPH KITK851225URINE DUOK852582GONI-KITK852480DERM-KITK851518MUELLER HINTON SENSITIVITY PLATE

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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

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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