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FDA 510(k)

BICARBONATE REAGENTS PRODUCT #7713 & #7714

K-Number: K900420 · 1990-03-01

ApplicantAmerican Research Products Co.
Decision Date1990-03-01
Product CodeJFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BICARBONATE REAGENTS PRODUCT #7713 & #7714 is the device name listed in this FDA 510(k) record. The listed applicant is American Research Products Co.. It received FDA 510(k) clearance on 1990-03-01 under 510(k) number K900420. 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 BICARBONATE REAGENTS PRODUCT #7713 & #7714?

BICARBONATE REAGENTS PRODUCT #7713 & #7714 is a medical device that received FDA 510(k) clearance on 1990-03-01. The listed applicant is American Research Products Co.. The 510(k) number is K900420.

When did BICARBONATE REAGENTS PRODUCT #7713 & #7714 receive FDA 510(k) clearance?

BICARBONATE REAGENTS PRODUCT #7713 & #7714 received FDA 510(k) clearance on 1990-03-01, under 510(k) number K900420.

Who is the listed applicant for BICARBONATE REAGENTS PRODUCT #7713 & #7714?

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

What is the FDA product code for BICARBONATE REAGENTS PRODUCT #7713 & #7714?

The FDA product code for BICARBONATE REAGENTS PRODUCT #7713 & #7714 is JFL.

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Other records listing American Research Products 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.

K942984BUN REAGENTK901527BIURET (COLORMETRIC), TOTAL PROTEINK901960IRON REAGENTS PRODUCT CODES 7725 AND 7726K901964PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463K900827COLORIMETRIC CHLORIDE PRODUCT #4314125K901702NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522

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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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