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FDA 510(k)

BUN REAGENT KIT #88108

K-Number: K800616 · 1980-04-10

ApplicantHi Chem, Inc.
Decision Date1980-04-10
Product CodeCDS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUN REAGENT KIT #88108 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 1980-04-10 under 510(k) number K800616. 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 BUN REAGENT KIT #88108?

BUN REAGENT KIT #88108 is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is Hi Chem, Inc.. The 510(k) number is K800616.

When did BUN REAGENT KIT #88108 receive FDA 510(k) clearance?

BUN REAGENT KIT #88108 received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800616.

Who is the listed applicant for BUN REAGENT KIT #88108?

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 BUN REAGENT KIT #88108?

The FDA product code for BUN REAGENT KIT #88108 is CDS.

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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: 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.K925550HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806Hichem DiagnosticsK860543BLOOD UREA NITROGEN (BUN) TESTCARDIlex Corp.K855091CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYSSen Tech Medical Corp.

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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