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)

H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME

K-Number: K811721 · 1981-07-16

ApplicantImmulok, Inc.
Decision Date1981-07-16
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME is the device name listed in this FDA 510(k) record. The listed applicant is Immulok, Inc.. It received FDA 510(k) clearance on 1981-07-16 under 510(k) number K811721. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME?

H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME is a medical device that received FDA 510(k) clearance on 1981-07-16. The listed applicant is Immulok, Inc.. The 510(k) number is K811721.

When did H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME receive FDA 510(k) clearance?

H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME received FDA 510(k) clearance on 1981-07-16, under 510(k) number K811721.

Who is the listed applicant for H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME?

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

What is the FDA product code for H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME?

The FDA product code for H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME is DFH.

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 Immulok, 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.

K830971HERPES SIMPLEX VIRUS TYPING REAGENTSK830342CULUTURE SET CHLAMYDIA ISOLATION ANDK830250CVT VIRAL TRANSPORTSK823304RIASET PROLACTIN RIA KITK822785FLUOROSET IMMUNOFLUORESCENT ANTIBODYK823055FLOUROSET IMMUNOFLUORESCENT ANTIBODY

View all 15 devices →

Related Devices (Code: DFH)

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.

K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDiazyme Laboratories, Inc.K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2SebiaK231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2SebiaK211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, 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.

↑