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FDA 510(k)

ENZYMATIC CO2 REAGENT SET

K-Number: K882497 · 1988-08-02

ApplicantAmerican Monitor Corp.
Decision Date1988-08-02
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC CO2 REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1988-08-02 under 510(k) number K882497. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYMATIC CO2 REAGENT SET?

ENZYMATIC CO2 REAGENT SET is a medical device that received FDA 510(k) clearance on 1988-08-02. The listed applicant is American Monitor Corp.. The 510(k) number is K882497.

When did ENZYMATIC CO2 REAGENT SET receive FDA 510(k) clearance?

ENZYMATIC CO2 REAGENT SET received FDA 510(k) clearance on 1988-08-02, under 510(k) number K882497.

Who is the listed applicant for ENZYMATIC CO2 REAGENT SET?

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

What is the FDA product code for ENZYMATIC CO2 REAGENT SET?

The FDA product code for ENZYMATIC CO2 REAGENT SET is KHS.

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Other records listing American Monitor Corp. 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.

K895999PHOSPHORUSK896000ASPARTATE AMINOTRANFERASE (AST)K896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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Related Devices (Code: KHS)

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.

K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann

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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