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FDA 510(k)

FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET

K-Number: K993590 · 1999-12-21

ApplicantPointe Scientific, Inc.,
Decision Date1999-12-21
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL 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 1999-12-21 under 510(k) number K993590. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET?

FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K993590.

When did FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET receive FDA 510(k) clearance?

FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET received FDA 510(k) clearance on 1999-12-21, under 510(k) number K993590.

Who is the listed applicant for FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL 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 FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET?

The FDA product code for FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET is LCP.

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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: LCP)

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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