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FDA 510(k)

PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS

K-Number: K881277 · 1988-04-25

ApplicantGen-Probe, Inc.
Decision Date1988-04-25
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS 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 1988-04-25 under 510(k) number K881277. The device is classified under product code LSL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS?

PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS is a medical device that received FDA 510(k) clearance on 1988-04-25. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K881277.

When did PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS receive FDA 510(k) clearance?

PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS received FDA 510(k) clearance on 1988-04-25, under 510(k) number K881277.

Who is the listed applicant for PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS?

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 PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS?

The FDA product code for PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS is LSL.

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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: LSL)

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.

K231329Aptima Neisseria gonorrhoeae AssayHologic, Inc.K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc.K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.K173840Xpert CT/NGCepheidK163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.K132270COBAS CT/NG V2.0 TESTRoche Molecular Systems, 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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