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FDA 510(k)

ALBUMIN QVET

K-Number: K943000 · 1994-12-13

ApplicantPrisma Systems
Decision Date1994-12-13
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN QVET is the device name listed in this FDA 510(k) record. The listed applicant is Prisma Systems. It received FDA 510(k) clearance on 1994-12-13 under 510(k) number K943000. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBUMIN QVET?

ALBUMIN QVET is a medical device that received FDA 510(k) clearance on 1994-12-13. The listed applicant is Prisma Systems. The 510(k) number is K943000.

When did ALBUMIN QVET receive FDA 510(k) clearance?

ALBUMIN QVET received FDA 510(k) clearance on 1994-12-13, under 510(k) number K943000.

Who is the listed applicant for ALBUMIN QVET?

The FDA 510(k) record lists Prisma Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALBUMIN QVET?

The FDA product code for ALBUMIN QVET is CIX.

Related Clinical Trials

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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Other records listing Prisma Systems 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.

K950177CK QVETK943027CHOLESTEROL QVETK943001MAGNESIUM QVETK942964LACTATE DEHYDROGENASE QVETK943042BUN QVETK942997ALKALINE PHOSPHATASE (ALKP) QVET

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Related Devices (Code: CIX)

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.

K251157Core MetabolicTruvian HealthK203248Albumin BCG2Abbott Ireland Diagnostics DivisionK200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct BilirubinMedicon Hellas S.AK191316VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc.K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.K131488ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENTAlfa Wassermann Diagnostics Technologies, LLC

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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