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FDA 510(k)

ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)

K-Number: K030528 · 2003-06-17

ApplicantClinical Data
Decision Date2003-06-17
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data. It received FDA 510(k) clearance on 2003-06-17 under 510(k) number K030528. The device is classified under product code JIY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)?

ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) is a medical device that received FDA 510(k) clearance on 2003-06-17. The listed applicant is Clinical Data. The 510(k) number is K030528.

When did ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) receive FDA 510(k) clearance?

ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) received FDA 510(k) clearance on 2003-06-17, under 510(k) number K030528.

Who is the listed applicant for ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)?

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

What is the FDA product code for ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)?

The FDA product code for ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) is JIY.

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Related Devices (Code: JIY)

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.

K061793DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATORDade Behring, Inc.K060264DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc.K051115SENTINEL IRON LIQUIDSentinel Ch. SrlK033983VITALAB IRON REAGENTClinical Data, Inc.K020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26Diagnostic Chemicals , Ltd.K013097WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003Wiener Laboratories Saic

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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