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FDA 510(k)

CARBON DIOXIDE REAGENT KIT

K-Number: K873129 · 1987-10-23

ApplicantA-Kem, Inc.
Decision Date1987-10-23
Product CodeJFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is A-Kem, Inc.. It received FDA 510(k) clearance on 1987-10-23 under 510(k) number K873129. 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 CARBON DIOXIDE REAGENT KIT?

CARBON DIOXIDE REAGENT KIT is a medical device that received FDA 510(k) clearance on 1987-10-23. The listed applicant is A-Kem, Inc.. The 510(k) number is K873129.

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

CARBON DIOXIDE REAGENT KIT received FDA 510(k) clearance on 1987-10-23, under 510(k) number K873129.

Who is the listed applicant for CARBON DIOXIDE REAGENT KIT?

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

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

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

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Other records listing A-Kem, 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.

K884224TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMSK884227CALIBRATOR STANDARD KIT FOR ASTRA SYSTEMK884225TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMSK884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSK882587A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEMK882586A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM

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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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