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)

RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS

K-Number: K871878 · 1987-10-28

ApplicantGen-Probe, Inc.
Decision Date1987-10-28
Product CodeLSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS 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 1987-10-28 under 510(k) number K871878. The device is classified under product code LSK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS?

RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS is a medical device that received FDA 510(k) clearance on 1987-10-28. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K871878.

When did RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS receive FDA 510(k) clearance?

RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS received FDA 510(k) clearance on 1987-10-28, under 510(k) number K871878.

Who is the listed applicant for RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS?

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 RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS?

The FDA product code for RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS is LSK.

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 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

View all 62 devices →

Related Devices (Code: LSK)

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.

K092704ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03Abbott Molecular, Inc.K010891MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01Digene Corp.K010892MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01Digene Corp.K990023HYBRID CAPTURE II CT-ID TESTDigene Corp.K920302PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAYGen-Probe, Inc.K920378PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATISGen-Probe, 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.

↑