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FDA 510(k)

ANTI-HUMAN KAPPA SERUM

K-Number: K791284 · 1979-11-27

ApplicantDiagnostica, Inc.
Decision Date1979-11-27
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-HUMAN KAPPA SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica, Inc.. It received FDA 510(k) clearance on 1979-11-27 under 510(k) number K791284. 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 ANTI-HUMAN KAPPA SERUM?

ANTI-HUMAN KAPPA SERUM is a medical device that received FDA 510(k) clearance on 1979-11-27. The listed applicant is Diagnostica, Inc.. The 510(k) number is K791284.

When did ANTI-HUMAN KAPPA SERUM receive FDA 510(k) clearance?

ANTI-HUMAN KAPPA SERUM received FDA 510(k) clearance on 1979-11-27, under 510(k) number K791284.

Who is the listed applicant for ANTI-HUMAN KAPPA SERUM?

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

What is the FDA product code for ANTI-HUMAN KAPPA SERUM?

The FDA product code for ANTI-HUMAN KAPPA SERUM is DFH.

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Other records listing Diagnostica, 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.

K002756EASE-A-CULTK823348H. INFLUENZA B ANTISERA FOR CIEK812434DIAGNOSTIC KITS & KIT COMPONENTSK800398PARACONTROL ABNORMAL IMMUNOGLOBULIN CONTK791281ANTI-HUMAN IGG SERUMK791283ANTI-HUMAN LAMBDA SERUM

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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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