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FDA 510(k)

LYSING REAGENT

K-Number: K832182 · 1983-08-12

ApplicantOmega Medical Diagnostics
Decision Date1983-08-12
Product CodeGGK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LYSING REAGENT 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 1983-08-12 under 510(k) number K832182. The device is classified under product code GGK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYSING REAGENT?

LYSING REAGENT is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Omega Medical Diagnostics. The 510(k) number is K832182.

When did LYSING REAGENT receive FDA 510(k) clearance?

LYSING REAGENT received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832182.

Who is the listed applicant for LYSING REAGENT?

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 LYSING REAGENT?

The FDA product code for LYSING REAGENT is GGK.

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.

K831619SODIUM HYPOCHLORITE 7%K831620SODIUM HYPOCHLORITE 3%K831618HEMOGLOBIN REAGENTK831617DILUENT

Related Devices (Code: GGK)

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.

K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter ImmunologyK883991KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTFisher Scientific Co., LLCK873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.Abbott DiagnosticsK863114PIASTRINITJ. D. Assoc.K863503HEMOLYSEReagent Laboratory, 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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