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FDA 510(k)

BECKMAN KAPPA LIGHT CHAIN REAGENT

K-Number: K884276 · 1988-11-16

ApplicantBeckman Instruments, Inc.
Decision Date1988-11-16
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BECKMAN KAPPA LIGHT CHAIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1988-11-16 under 510(k) number K884276. 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 BECKMAN KAPPA LIGHT CHAIN REAGENT?

BECKMAN KAPPA LIGHT CHAIN REAGENT is a medical device that received FDA 510(k) clearance on 1988-11-16. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K884276.

When did BECKMAN KAPPA LIGHT CHAIN REAGENT receive FDA 510(k) clearance?

BECKMAN KAPPA LIGHT CHAIN REAGENT received FDA 510(k) clearance on 1988-11-16, under 510(k) number K884276.

Who is the listed applicant for BECKMAN KAPPA LIGHT CHAIN REAGENT?

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

What is the FDA product code for BECKMAN KAPPA LIGHT CHAIN REAGENT?

The FDA product code for BECKMAN KAPPA LIGHT CHAIN REAGENT is DFH.

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Other records listing Beckman Instruments, Inc. as applicant

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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.

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