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FDA 510(k)

HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806

K-Number: K925550 · 1993-04-20

ApplicantHichem Diagnostics
Decision Date1993-04-20
Product CodeCDS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1993-04-20 under 510(k) number K925550. The device is classified under product code CDS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806?

HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 is a medical device that received FDA 510(k) clearance on 1993-04-20. The listed applicant is Hichem Diagnostics. The 510(k) number is K925550.

When did HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 receive FDA 510(k) clearance?

HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 received FDA 510(k) clearance on 1993-04-20, under 510(k) number K925550.

Who is the listed applicant for HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806?

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 BUN REAGENT KIT,PRODUCT NUMBER 88806?

The FDA product code for HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 is CDS.

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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 70008K953863HICHEM ISE STANDARDS KIT 70011K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953862HICHEM ISEKCI SOLUTION KIT 70010

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Related Devices (Code: CDS)

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.

K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestEpocal, Inc.K040973BUN REAGENTGenchem, Inc.K033056BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENTDiamond Diagnostics, Inc.K860543BLOOD UREA NITROGEN (BUN) TESTCARDIlex Corp.K855091CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYSSen Tech Medical Corp.K812308LANCER BUN RATE REAGENT KITSherwood Medical Co.

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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