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FDA 510(k)

AMYLASE QVET

K-Number: K942961 · 1994-12-09

ApplicantPrisma Systems
Decision Date1994-12-09
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE 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 1994-12-09 under 510(k) number K942961. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMYLASE QVET?

AMYLASE QVET is a medical device that received FDA 510(k) clearance on 1994-12-09. The listed applicant is Prisma Systems. The 510(k) number is K942961.

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

AMYLASE QVET received FDA 510(k) clearance on 1994-12-09, under 510(k) number K942961.

Who is the listed applicant for AMYLASE 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 AMYLASE QVET?

The FDA product code for AMYLASE QVET is JFJ.

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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: JFJ)

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.

K210633Amylase2Abbott Ireland Diagnostics DivisionK191454Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc.K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALBiosystems S.A.K130685HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYHitachi Chemical Diagnostics, Inc.K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIElitechgroupK091846SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607Beckman Coulter, Inc.

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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