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FDA 510(k)

ANALYTE IRON/TECHNICON CHEM 1 SYSTEM

K-Number: K860799 · 1986-04-03

ApplicantTechnicon Instruments Corp.
Decision Date1986-04-03
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANALYTE IRON/TECHNICON CHEM 1 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1986-04-03 under 510(k) number K860799. 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 ANALYTE IRON/TECHNICON CHEM 1 SYSTEM?

ANALYTE IRON/TECHNICON CHEM 1 SYSTEM is a medical device that received FDA 510(k) clearance on 1986-04-03. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K860799.

When did ANALYTE IRON/TECHNICON CHEM 1 SYSTEM receive FDA 510(k) clearance?

ANALYTE IRON/TECHNICON CHEM 1 SYSTEM received FDA 510(k) clearance on 1986-04-03, under 510(k) number K860799.

Who is the listed applicant for ANALYTE IRON/TECHNICON CHEM 1 SYSTEM?

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

What is the FDA product code for ANALYTE IRON/TECHNICON CHEM 1 SYSTEM?

The FDA product code for ANALYTE IRON/TECHNICON CHEM 1 SYSTEM is JIY.

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Other records listing Technicon Instruments Corp. 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.

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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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