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FDA 510(k)

HI CHEM CREATININE REAGENT (PRODUCT #88809)

K-Number: K890671 · 1989-05-09

ApplicantHichem Diagnostics
Decision Date1989-05-09
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM CREATININE REAGENT (PRODUCT #88809) is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1989-05-09 under 510(k) number K890671. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI CHEM CREATININE REAGENT (PRODUCT #88809)?

HI CHEM CREATININE REAGENT (PRODUCT #88809) is a medical device that received FDA 510(k) clearance on 1989-05-09. The listed applicant is Hichem Diagnostics. The 510(k) number is K890671.

When did HI CHEM CREATININE REAGENT (PRODUCT #88809) receive FDA 510(k) clearance?

HI CHEM CREATININE REAGENT (PRODUCT #88809) received FDA 510(k) clearance on 1989-05-09, under 510(k) number K890671.

Who is the listed applicant for HI CHEM CREATININE REAGENT (PRODUCT #88809)?

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 HI CHEM CREATININE REAGENT (PRODUCT #88809)?

The FDA product code for HI CHEM CREATININE REAGENT (PRODUCT #88809) is CGX.

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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: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc.

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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