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FDA 510(k)

CO2 REAGENT SET

K-Number: K864313 · 1987-03-13

ApplicantHf Scientific, Inc.
Decision Date1987-03-13
Product CodeCIE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CO2 REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Hf Scientific, Inc.. It received FDA 510(k) clearance on 1987-03-13 under 510(k) number K864313. The device is classified under product code CIE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO2 REAGENT SET?

CO2 REAGENT SET is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Hf Scientific, Inc.. The 510(k) number is K864313.

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

CO2 REAGENT SET received FDA 510(k) clearance on 1987-03-13, under 510(k) number K864313.

Who is the listed applicant for CO2 REAGENT SET?

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

What is the FDA product code for CO2 REAGENT SET?

The FDA product code for CO2 REAGENT SET is CIE.

Related Clinical Trials

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.

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Other records listing Hf Scientific, 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.

K882801RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.K880967MICRO CO2 APPARATUSK874429HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12K864862REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.

Related Devices (Code: CIE)

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.

K904761P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENTInstrumentation Laboratory COK880967MICRO CO2 APPARATUSHf Scientific, Inc.K832071TOTAL CO2 REAGENT SETAmerican Research Products Co.K820091AIRMED SMOKE EVACUATION & FILTERJames L. Geraci & Associates, Inc.K800524SERALYZER REFLECTANCE PHOTOMETER/CALIB.Miles Laboratories, Inc.K771610CARBON DIOXIDE ANALYZERCorning Medical & Scientific

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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