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FDA 510(k)

HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813

K-Number: K925553 · 1993-02-12

ApplicantHichem Diagnostics
Decision Date1993-02-12
Product CodeJFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K925553. 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 HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813?

HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Hichem Diagnostics. The 510(k) number is K925553.

When did HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 receive FDA 510(k) clearance?

HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 received FDA 510(k) clearance on 1993-02-12, under 510(k) number K925553.

Who is the listed applicant for HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813?

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

What is the FDA product code for HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813?

The FDA product code for HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 is JFL.

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Other records listing Hichem Diagnostics 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.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011

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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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