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FDA 510(k)

ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10

K-Number: K060359 · 2006-04-14

ApplicantDenka Seiken Co., Ltd.
Decision Date2006-04-14
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 is the device name listed in this FDA 510(k) record. The listed applicant is Denka Seiken Co., Ltd.. It received FDA 510(k) clearance on 2006-04-14 under 510(k) number K060359. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10?

ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 is a medical device that received FDA 510(k) clearance on 2006-04-14. The listed applicant is Denka Seiken Co., Ltd.. The 510(k) number is K060359.

When did ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 receive FDA 510(k) clearance?

ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 received FDA 510(k) clearance on 2006-04-14, under 510(k) number K060359.

Who is the listed applicant for ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10?

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

What is the FDA product code for ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10?

The FDA product code for ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 is JIT.

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 Co., Ltd. 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.

K161679s LDL-EX SEIKENK043264LDL-EX SEIKEN ASSAY KITK041090HDL-EX SEIKEN ASSAY KITK030546CRP (II) CALIBRATORSK030545CRP-LATEX (II)X2 SEIKEN ASSAY KIT

Related Devices (Code: JIT)

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.

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163521Lumipulse G LH CalibratorsFujirebio Diagnostics,Inc.

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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