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FDA 510(k)

ENZYMATIC CO2 REAGENT, MODIFICATION

K-Number: K932267 · 1993-09-24

ApplicantIntersect Systems, Inc.
Decision Date1993-09-24
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC CO2 REAGENT, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Systems, Inc.. It received FDA 510(k) clearance on 1993-09-24 under 510(k) number K932267. 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, MODIFICATION?

ENZYMATIC CO2 REAGENT, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-09-24. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K932267.

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

ENZYMATIC CO2 REAGENT, MODIFICATION received FDA 510(k) clearance on 1993-09-24, under 510(k) number K932267.

Who is the listed applicant for ENZYMATIC CO2 REAGENT, MODIFICATION?

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

What is the FDA product code for ENZYMATIC CO2 REAGENT, MODIFICATION?

The FDA product code for ENZYMATIC CO2 REAGENT, MODIFICATION is KHS.

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Other records listing Intersect Systems, 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.

K021636ALBUMIN REAGENTK011972DIRECT BILIRUBIN REAGENTK011692HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENTK003892TOTAL BILIRUBIN REAGENTK983937DUAL VIAL CREATININE REAGENTK974833CK-NAC REAGENT

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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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