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FDA 510(k)

MICROALBUMIN REAGENT SET AND CALIBRATORS

K-Number: K023860 · 2003-04-28

ApplicantPointe Scientific, Inc.,
Decision Date2003-04-28
Product CodeDDZ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MICROALBUMIN REAGENT SET AND CALIBRATORS 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 2003-04-28 under 510(k) number K023860. The device is classified under product code DDZ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROALBUMIN REAGENT SET AND CALIBRATORS?

MICROALBUMIN REAGENT SET AND CALIBRATORS is a medical device that received FDA 510(k) clearance on 2003-04-28. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K023860.

When did MICROALBUMIN REAGENT SET AND CALIBRATORS receive FDA 510(k) clearance?

MICROALBUMIN REAGENT SET AND CALIBRATORS received FDA 510(k) clearance on 2003-04-28, under 510(k) number K023860.

Who is the listed applicant for MICROALBUMIN REAGENT SET AND CALIBRATORS?

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 MICROALBUMIN REAGENT SET AND CALIBRATORS?

The FDA product code for MICROALBUMIN REAGENT SET AND CALIBRATORS is DDZ.

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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: DDZ)

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.

K050576MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-HGood Biotech Corp.K002674RANDOX MICROALBUMINRandox Laboratories, Ltd.K831902FLUORESCEIN CONJUGATED IMMUNOGLOBIN-Dako Corp.

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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