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FDA 510(k)

IRON/TIBC REAGENT

K-Number: K935712 · 1995-09-20

ApplicantHorizon Diagnostics, Inc.
Decision Date1995-09-20
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRON/TIBC REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Horizon Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-09-20 under 510(k) number K935712. 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 IRON/TIBC REAGENT?

IRON/TIBC REAGENT is a medical device that received FDA 510(k) clearance on 1995-09-20. The listed applicant is Horizon Diagnostics, Inc.. The 510(k) number is K935712.

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

IRON/TIBC REAGENT received FDA 510(k) clearance on 1995-09-20, under 510(k) number K935712.

Who is the listed applicant for IRON/TIBC REAGENT?

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

What is the FDA product code for IRON/TIBC REAGENT?

The FDA product code for IRON/TIBC REAGENT is JIY.

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Other records listing Horizon Diagnostics, 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.

K971566CREATINE KINASE-MB REAGENT SETK933722HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENTK930678AMYLASEK934533BUN-300/BUN-500 UREA NITROGEN REAGENTK930679DIRECT BILIRUBINK930074IN-VITRO DIAGNOSTIC REAGENT SET

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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.K030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)Clinical DataK020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26Diagnostic Chemicals , Ltd.

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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