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FDA 510(k)

NSI CARBON DIOXIDE REAGENT KIT

K-Number: K800586 · 1980-04-04

ApplicantNobel Scientific Industries, Inc.
Decision Date1980-04-04
Product CodeJFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NSI CARBON DIOXIDE REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Scientific Industries, Inc.. It received FDA 510(k) clearance on 1980-04-04 under 510(k) number K800586. The device is classified under product code JFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NSI CARBON DIOXIDE REAGENT KIT?

NSI CARBON DIOXIDE REAGENT KIT is a medical device that received FDA 510(k) clearance on 1980-04-04. The listed applicant is Nobel Scientific Industries, Inc.. The 510(k) number is K800586.

When did NSI CARBON DIOXIDE REAGENT KIT receive FDA 510(k) clearance?

NSI CARBON DIOXIDE REAGENT KIT received FDA 510(k) clearance on 1980-04-04, under 510(k) number K800586.

Who is the listed applicant for NSI CARBON DIOXIDE REAGENT KIT?

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

What is the FDA product code for NSI CARBON DIOXIDE REAGENT KIT?

The FDA product code for NSI CARBON DIOXIDE REAGENT KIT is JFL.

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Other records listing Nobel Scientific Industries, 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.

K854717NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928K854716NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909K854718NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926K850944NSI LYSING-D REAGENT -4000 MLK844782NSI ELT-D DILUTING FLUID 4000MLK823283FLUSHING SOLUTION

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Related Devices (Code: JFL)

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.

K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K040975GENCHEM CO2 ACID REAGENTGenchem, Inc.K014034MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)Beckman Coulter, Inc.K963541SIGMA DIAGNOSTICS CO2 ACID REAGENTSigma Diagnostics, Inc.K963538SIGMA DIAGNOSTICS CO2ALKALINE BUFFERSigma Diagnostics, Inc.K963540SIGMA DIAGNOSTICS ELECTROLYTE BUFFERSigma Diagnostics, 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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