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FDA 510(k)

GEN-PROBE PACE SYSTEM URINE SCREEN

K-Number: K892216 · 1989-09-15

ApplicantGen-Probe, Inc.
Decision Date1989-09-15
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE PACE SYSTEM URINE SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe, Inc.. It received FDA 510(k) clearance on 1989-09-15 under 510(k) number K892216. 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 GEN-PROBE PACE SYSTEM URINE SCREEN?

GEN-PROBE PACE SYSTEM URINE SCREEN is a medical device that received FDA 510(k) clearance on 1989-09-15. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K892216.

When did GEN-PROBE PACE SYSTEM URINE SCREEN receive FDA 510(k) clearance?

GEN-PROBE PACE SYSTEM URINE SCREEN received FDA 510(k) clearance on 1989-09-15, under 510(k) number K892216.

Who is the listed applicant for GEN-PROBE PACE SYSTEM URINE SCREEN?

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

What is the FDA product code for GEN-PROBE PACE SYSTEM URINE SCREEN?

The FDA product code for GEN-PROBE PACE SYSTEM URINE SCREEN is JXA.

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Other records listing Gen-Probe, 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.

K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERK111409APTIMA COMBO 2 ASSAYK063664GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091K063451GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199K062440GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091K061413APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM

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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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