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FDA 510(k)

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

K-Number: K220001 · 2022-08-04

ApplicantDiazyme Laboratories, Inc.
Decision Date2022-08-04
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay is a medical device manufactured by Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2022-08-04 under approval number K220001. 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 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay?

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay is a medical device that received FDA 510(k) clearance on 2022-08-04. It is manufactured by Diazyme Laboratories, Inc.. The 510(k) number is K220001.

When was Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay approved by the FDA?

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay received FDA 510(k) clearance on 2022-08-04, under approval number K220001.

What company makes Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay?

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay is manufactured by Diazyme Laboratories, Inc..

What is the FDA product code for Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay?

The FDA product code for Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay is DFH.

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Related PubMed Literature

PMID: 42043121 Validation of the Epi2SensA Method Using the EpiDerm™ Model for Skin Sensitization Testing Under OECD TG442D. Toxics (2026) PMID: 40496061 An improved reporter gene assay for evaluating the biological activity of recombinant human growth hormone. Journal of pharmaceutical analysis (2025)

Other Devices by Diazyme Laboratories, Inc.

K180209Diazyme 1,5-AG Assay K181438Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay K180074Diazyme Lipoprotein (a) Assay K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer K203136Diazyme PLAC® Test for Lp-PLA2 Activity K211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

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Related Devices (Code: DFH)

K153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain CalibratorDiazyme Laboratories K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2Siemens Healthcare Diagnostics Products GmbH K182098N Latex FLC kappa assay, N Latex FLC lambda assaySiemens Healthcare Diagnostics Products GmbH K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitThe Binding Site Group , Ltd. K181438Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc. K190879N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH

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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