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FDA 510(k)

MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

K-Number: K002199 · 2000-11-20

ApplicantPointe Scientific, Inc.,
Decision Date2000-11-20
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 2000-11-20 under 510(k) number K002199. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET?

MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET is a medical device that received FDA 510(k) clearance on 2000-11-20. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K002199.

When did MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET receive FDA 510(k) clearance?

MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET received FDA 510(k) clearance on 2000-11-20, under 510(k) number K002199.

Who is the listed applicant for MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET?

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

What is the FDA product code for MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET?

The FDA product code for MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET is CFR.

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Other records listing Pointe 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

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Related Devices (Code: CFR)

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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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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