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FDA 510(k)

BUN REAGENT KIT

K-Number: K873132 · 1987-10-23

ApplicantA-Kem, Inc.
Decision Date1987-10-23
Product CodeLFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUN REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is A-Kem, Inc.. It received FDA 510(k) clearance on 1987-10-23 under 510(k) number K873132. The device is classified under product code LFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUN REAGENT KIT?

BUN REAGENT KIT is a medical device that received FDA 510(k) clearance on 1987-10-23. The listed applicant is A-Kem, Inc.. The 510(k) number is K873132.

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

BUN REAGENT KIT received FDA 510(k) clearance on 1987-10-23, under 510(k) number K873132.

Who is the listed applicant for BUN REAGENT KIT?

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

What is the FDA product code for BUN REAGENT KIT?

The FDA product code for BUN REAGENT KIT is LFP.

Related Clinical Trials

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Other records listing A-Kem, 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.

K884224TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMSK884227CALIBRATOR STANDARD KIT FOR ASTRA SYSTEMK884225TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMSK884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSK882587A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEMK882586A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM

View all 13 devices →

Related Devices (Code: LFP)

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.

K990039GAMBRO DQM 200Gambro HealthcareK992847HICHEM BUN REAGENTElan Holdings, Inc.K963537SIGMA DIAGNOSTICS BUN REAGENTSigma Diagnostics, Inc.K933679SIGMA BUN REAGENTSigma Chemical Co.K812945LIQUILYME BUN REAGENTAmresco, 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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