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FDA 510(k)

LIQUID ALKALINE PHOSHATASE REAGENT SET

K-Number: K973588 · 1997-10-22

ApplicantPointe Scientific, Inc.,
Decision Date1997-10-22
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUID ALKALINE PHOSHATASE 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 1997-10-22 under 510(k) number K973588. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIQUID ALKALINE PHOSHATASE REAGENT SET?

LIQUID ALKALINE PHOSHATASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1997-10-22. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K973588.

When did LIQUID ALKALINE PHOSHATASE REAGENT SET receive FDA 510(k) clearance?

LIQUID ALKALINE PHOSHATASE REAGENT SET received FDA 510(k) clearance on 1997-10-22, under 510(k) number K973588.

Who is the listed applicant for LIQUID ALKALINE PHOSHATASE 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 LIQUID ALKALINE PHOSHATASE REAGENT SET?

The FDA product code for LIQUID ALKALINE PHOSHATASE REAGENT SET is CJE.

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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: CJE)

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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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