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FDA 510(k)

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay

K-Number: K253358 · 2025-12-19

ApplicantDiazyme Laboratories, Inc.
Decision Date2025-12-19
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Diazyme Human Kappa (k) 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 2025-12-19 under approval number K253358. 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 (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay?

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Diazyme Laboratories, Inc.. The 510(k) number is K253358.

When was Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay approved by the FDA?

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay received FDA 510(k) clearance on 2025-12-19, under approval number K253358.

What company makes Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay?

Diazyme Human Kappa (k) 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 (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay?

The FDA product code for Diazyme Human Kappa (k) 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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