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FDA 510(k)

SIGMA BUN REAGENT

K-Number: K933679 · 1993-12-17

ApplicantSigma Chemical Co.
Decision Date1993-12-17
Product CodeLFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA BUN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1993-12-17 under 510(k) number K933679. 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 SIGMA BUN REAGENT?

SIGMA BUN REAGENT is a medical device that received FDA 510(k) clearance on 1993-12-17. The listed applicant is Sigma Chemical Co.. The 510(k) number is K933679.

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

SIGMA BUN REAGENT received FDA 510(k) clearance on 1993-12-17, under 510(k) number K933679.

Who is the listed applicant for SIGMA BUN REAGENT?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGMA BUN REAGENT?

The FDA product code for SIGMA BUN REAGENT is LFP.

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Other records listing Sigma Chemical Co. 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933703SIGMA WASH CONCENTRATE SOLUTIONK933692SIGMA CO2 ACID REAGENT

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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 HealthcareK992847HICHEM BUN REAGENTElan Holdings, Inc.K963537SIGMA DIAGNOSTICS BUN REAGENTSigma Diagnostics, Inc.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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