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FDA 510(k)

HICHEM BUN REAGENT

K-Number: K992847 · 1999-10-14

ApplicantElan Holdings, Inc.
Decision Date1999-10-14
Product CodeLFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM BUN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Elan Holdings, Inc.. It received FDA 510(k) clearance on 1999-10-14 under 510(k) number K992847. 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 HICHEM BUN REAGENT?

HICHEM BUN REAGENT is a medical device that received FDA 510(k) clearance on 1999-10-14. The listed applicant is Elan Holdings, Inc.. The 510(k) number is K992847.

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

HICHEM BUN REAGENT received FDA 510(k) clearance on 1999-10-14, under 510(k) number K992847.

Who is the listed applicant for HICHEM BUN REAGENT?

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

What is the FDA product code for HICHEM BUN REAGENT?

The FDA product code for HICHEM BUN REAGENT is LFP.

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Other records listing Elan Holdings, Inc. as applicant

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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 HealthcareK963537SIGMA DIAGNOSTICS BUN REAGENTSigma Diagnostics, Inc.K933679SIGMA BUN REAGENTSigma Chemical Co.K873132BUN REAGENT KITA-Kem, Inc.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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