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FDA 510(k)

ION 2 REAGENT KI

K-Number: K851350 · 1985-04-29

ApplicantHi Chem, Inc.
Decision Date1985-04-29
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ION 2 REAGENT KI is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1985-04-29 under 510(k) number K851350. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ION 2 REAGENT KI?

ION 2 REAGENT KI is a medical device that received FDA 510(k) clearance on 1985-04-29. The listed applicant is Hi Chem, Inc.. The 510(k) number is K851350.

When did ION 2 REAGENT KI receive FDA 510(k) clearance?

ION 2 REAGENT KI received FDA 510(k) clearance on 1985-04-29, under 510(k) number K851350.

Who is the listed applicant for ION 2 REAGENT KI?

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

What is the FDA product code for ION 2 REAGENT KI?

The FDA product code for ION 2 REAGENT KI is CEM.

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Other records listing Hi Chem, 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.

K960084HICHEM GLUCOSE/HK REAGENT KITK951818HICHEM ALT REAGENT KITK943684HICHEM ENZYME VERIFIER KITK941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808K902673HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STNDK863617ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)

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Related Devices (Code: CEM)

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.

K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche DiagnosticsK241037ABL90 FLEX PLUS SystemRadiometer Medicals ApsK220396EasyStat 300Medica CorporationK230890ISE ElectrodesRandox Laboratories, Ltd.K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.

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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