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FDA 510(k)

ALCOHOL REAGENT SET

K-Number: K972725 · 1997-09-25

ApplicantPointe Scientific, Inc.,
Decision Date1997-09-25
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ALCOHOL 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 1997-09-25 under 510(k) number K972725. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALCOHOL REAGENT SET?

ALCOHOL REAGENT SET is a medical device that received FDA 510(k) clearance on 1997-09-25. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K972725.

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

ALCOHOL REAGENT SET received FDA 510(k) clearance on 1997-09-25, under 510(k) number K972725.

Who is the listed applicant for ALCOHOL 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 ALCOHOL REAGENT SET?

The FDA product code for ALCOHOL REAGENT SET is DIC.

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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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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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