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FDA 510(k)

LP(A)-LATEX SEIKEN ASSAY KIT

K-Number: K013359 · 2002-03-08

ApplicantDenka Seiken'S
Decision Date2002-03-08
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LP(A)-LATEX SEIKEN ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Denka Seiken'S. It received FDA 510(k) clearance on 2002-03-08 under 510(k) number K013359. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LP(A)-LATEX SEIKEN ASSAY KIT?

LP(A)-LATEX SEIKEN ASSAY KIT is a medical device that received FDA 510(k) clearance on 2002-03-08. The listed applicant is Denka Seiken'S. The 510(k) number is K013359.

When did LP(A)-LATEX SEIKEN ASSAY KIT receive FDA 510(k) clearance?

LP(A)-LATEX SEIKEN ASSAY KIT received FDA 510(k) clearance on 2002-03-08, under 510(k) number K013359.

Who is the listed applicant for LP(A)-LATEX SEIKEN ASSAY KIT?

The FDA 510(k) record lists Denka Seiken'S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LP(A)-LATEX SEIKEN ASSAY KIT?

The FDA product code for LP(A)-LATEX SEIKEN ASSAY KIT is DFC.

Related Clinical Trials

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.

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Other records listing Denka Seiken'S 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.

K011400MRSA-SCREENK011958CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KITK981734VTEC-RPLA SEIKEN

Related Devices (Code: DFC)

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.

K253069Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc.K241220Tina-quant Lipoprotein(a) Gen.2 MolarityRoche Diagnostics OperationsK211058Lp(a) UltraSENTINEL CH. SpAK180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc.K123046ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORSiemens Healthcare Diagnostics, Inc.K122722COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160Roche Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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