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FDA 510(k)

MODIFIED INTENDED USE OF CLEANING REAGENT KIT

K-Number: K890184 · 1989-02-07

ApplicantHichem Diagnostics
Decision Date1989-02-07
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED INTENDED USE OF CLEANING REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1989-02-07 under 510(k) number K890184. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED INTENDED USE OF CLEANING REAGENT KIT?

MODIFIED INTENDED USE OF CLEANING REAGENT KIT is a medical device that received FDA 510(k) clearance on 1989-02-07. The listed applicant is Hichem Diagnostics. The 510(k) number is K890184.

When did MODIFIED INTENDED USE OF CLEANING REAGENT KIT receive FDA 510(k) clearance?

MODIFIED INTENDED USE OF CLEANING REAGENT KIT received FDA 510(k) clearance on 1989-02-07, under 510(k) number K890184.

Who is the listed applicant for MODIFIED INTENDED USE OF CLEANING REAGENT KIT?

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

What is the FDA product code for MODIFIED INTENDED USE OF CLEANING REAGENT KIT?

The FDA product code for MODIFIED INTENDED USE OF CLEANING REAGENT KIT is JJE.

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Other records listing Hichem Diagnostics 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.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011

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Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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