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FDA 510(k)

VITALAB IRON REAGENT

K-Number: K033983 · 2004-05-21

ApplicantClinical Data, Inc.
Decision Date2004-05-21
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITALAB IRON REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 2004-05-21 under 510(k) number K033983. 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 VITALAB IRON REAGENT?

VITALAB IRON REAGENT is a medical device that received FDA 510(k) clearance on 2004-05-21. The listed applicant is Clinical Data, Inc.. The 510(k) number is K033983.

When did VITALAB IRON REAGENT receive FDA 510(k) clearance?

VITALAB IRON REAGENT received FDA 510(k) clearance on 2004-05-21, under 510(k) number K033983.

Who is the listed applicant for VITALAB IRON REAGENT?

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

What is the FDA product code for VITALAB IRON REAGENT?

The FDA product code for VITALAB IRON REAGENT is JIY.

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Other records listing Clinical Data, Inc. 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.

K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)K052591NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KITK040631VITALAB DIRECT BILIRUBIN REAGENTK040534VITALAB AMYLASE REAGENTK034000VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATORK040508VITALAB MAGNESIUM REAGENT

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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. SrlK030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)Clinical DataK020816IRON-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

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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