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FDA 510(k)

CRP (II) CALIBRATORS

K-Number: K030546 · 2003-06-02

ApplicantDenka Seiken Co., Ltd.
Decision Date2003-06-02
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CRP (II) CALIBRATORS 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 2003-06-02 under 510(k) number K030546. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRP (II) CALIBRATORS?

CRP (II) CALIBRATORS is a medical device that received FDA 510(k) clearance on 2003-06-02. The listed applicant is Denka Seiken Co., Ltd.. The 510(k) number is K030546.

When did CRP (II) CALIBRATORS receive FDA 510(k) clearance?

CRP (II) CALIBRATORS received FDA 510(k) clearance on 2003-06-02, under 510(k) number K030546.

Who is the listed applicant for CRP (II) CALIBRATORS?

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 CRP (II) CALIBRATORS?

The FDA product code for CRP (II) CALIBRATORS is JIS.

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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 SEIKENK060359ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10K043264LDL-EX SEIKEN ASSAY KITK041090HDL-EX SEIKEN ASSAY KITK030545CRP-LATEX (II)X2 SEIKEN ASSAY KIT

Related Devices (Code: JIS)

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.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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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