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FDA 510(k)

KAPPA SERUM (FREE) ANTI-HUMAN

K-Number: K781027 · 1978-07-27

ApplicantIcl Scientific
Decision Date1978-07-27
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KAPPA SERUM (FREE) ANTI-HUMAN is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K781027. 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 KAPPA SERUM (FREE) ANTI-HUMAN?

KAPPA SERUM (FREE) ANTI-HUMAN is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is Icl Scientific. The 510(k) number is K781027.

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

KAPPA SERUM (FREE) ANTI-HUMAN received FDA 510(k) clearance on 1978-07-27, under 510(k) number K781027.

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

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

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

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

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Other records listing Icl Scientific 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.

K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLK843565KOVA TROL I,II, III HUMAN URINE-DRIEDK833761THERAPEUTIC DRUG CONTROLK832823ENZYMUNE-TEST TSHK831383EVENT-TEST SLIDEK823199ENZYME-TEST DIGOXIN

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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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