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)

RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE

K-Number: K872082 · 1987-07-31

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1987-07-31
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1987-07-31 under 510(k) number K872082. The device is classified under product code LKT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE?

RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE is a medical device that received FDA 510(k) clearance on 1987-07-31. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K872082.

When did RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE receive FDA 510(k) clearance?

RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE received FDA 510(k) clearance on 1987-07-31, under 510(k) number K872082.

Who is the listed applicant for RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE?

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

What is the FDA product code for RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE?

The FDA product code for RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE is LKT.

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 Medical Diagnostic Technologies, 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.

K062229CTC WORKSTATION, MODEL 2200K972209SPECTROLYSE HEPARIN (ANTI-IIA)K963106CHROMOLIZE PAI-1 KITK960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)K962489CHROMOLIZE TPA ASSAY KITK960438TINTELIZE PAI-1 KIT

View all 57 devices →

Related Devices (Code: LKT)

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.

K081928D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.K983336PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1Diagnostic Products Corp.K943317PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)Diagnostic Products Corp.K942173RSV ANTIGEN TESTNeogenexK912842RSV-MAB TESTGull Laboratories, Inc.K912838BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNOBaxter Diagnostics, 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.

↑