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)

LIGHT DIAGNOSTICS RABIES DFA REAGENT

K-Number: K972975 · 1998-12-22

ApplicantLight Diagnostics
Decision Date1998-12-22
Product CodeGOI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIGHT DIAGNOSTICS RABIES DFA REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Light Diagnostics. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K972975. The device is classified under product code GOI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHT DIAGNOSTICS RABIES DFA REAGENT?

LIGHT DIAGNOSTICS RABIES DFA REAGENT is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Light Diagnostics. The 510(k) number is K972975.

When did LIGHT DIAGNOSTICS RABIES DFA REAGENT receive FDA 510(k) clearance?

LIGHT DIAGNOSTICS RABIES DFA REAGENT received FDA 510(k) clearance on 1998-12-22, under 510(k) number K972975.

Who is the listed applicant for LIGHT DIAGNOSTICS RABIES DFA REAGENT?

The FDA 510(k) record lists Light Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIGHT DIAGNOSTICS RABIES DFA REAGENT?

The FDA product code for LIGHT DIAGNOSTICS RABIES DFA REAGENT is GOI.

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 Light Diagnostics 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.

K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYK990141LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295K974302LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BK951821CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK940017POLIOVIRUS 3 MONOCLONAL ANTIBODY

View all 19 devices →

Related Devices (Code: GOI)

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.

K820499FITC ANTI-RABIES MONOCLONAL GLOBULINCentocor, 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.

↑