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)

SODIUM HYPOCHLORITE 7%

K-Number: K831619 · 1983-07-28

ApplicantOmega Medical Diagnostics
Decision Date1983-07-28
Product CodePPM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

SODIUM HYPOCHLORITE 7% is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Diagnostics. It received FDA 510(k) clearance on 1983-07-28 under 510(k) number K831619. The device is classified under product code PPM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODIUM HYPOCHLORITE 7%?

SODIUM HYPOCHLORITE 7% is a medical device that received FDA 510(k) clearance on 1983-07-28. The listed applicant is Omega Medical Diagnostics. The 510(k) number is K831619.

When did SODIUM HYPOCHLORITE 7% receive FDA 510(k) clearance?

SODIUM HYPOCHLORITE 7% received FDA 510(k) clearance on 1983-07-28, under 510(k) number K831619.

Who is the listed applicant for SODIUM HYPOCHLORITE 7%?

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

What is the FDA product code for SODIUM HYPOCHLORITE 7%?

The FDA product code for SODIUM HYPOCHLORITE 7% is PPM.

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 Omega Medical 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.

K832182LYSING REAGENTK831620SODIUM HYPOCHLORITE 3%K831618HEMOGLOBIN REAGENTK831617DILUENT

Related Devices (Code: PPM)

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.

K871533TOMTEC GRAM STAINER DECOLORIZERRemel Co.K863550POTASSIUM HYDROXIDE 10% W/VReagent Laboratory, Inc.K861890100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2Richard-Allan Medical Ind., Inc.K850916SPRAYFIXSurgipath Medical Industries, Inc.K850737TRANSPORT CULTURE MEDIUMRoseville Medical LaboratoriesuK8508450.85% SALINEMicro Media Laboratories

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.

↑