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FDA 510(k)

ALKALINE PHOSPHATASE (ALKP) QVET

K-Number: K942997 · 1994-12-29

ApplicantPrisma Systems
Decision Date1994-12-29
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE (ALKP) 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 1994-12-29 under 510(k) number K942997. 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 ALKALINE PHOSPHATASE (ALKP) QVET?

ALKALINE PHOSPHATASE (ALKP) QVET is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is Prisma Systems. The 510(k) number is K942997.

When did ALKALINE PHOSPHATASE (ALKP) QVET receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE (ALKP) QVET received FDA 510(k) clearance on 1994-12-29, under 510(k) number K942997.

Who is the listed applicant for ALKALINE PHOSPHATASE (ALKP) 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 ALKALINE PHOSPHATASE (ALKP) QVET?

The FDA product code for ALKALINE PHOSPHATASE (ALKP) QVET is CJE.

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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 QVETK943042BUN QVETK942963GLUCOSE QVETK942964LACTATE DEHYDROGENASE QVETK943001MAGNESIUM QVET

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Related Devices (Code: CJE)

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.

K251074Tru Liver Health Test PanelTruvian HealthK240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK223317Alkaline Phosphatase2Abbott Ireland Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)

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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