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FDA 510(k)

PROCHEM CHEMISTRY ANALYZER

K-Number: K944028 · 1994-11-30

ApplicantPrisma Systems
Decision Date1994-11-30
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROCHEM CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Prisma Systems. It received FDA 510(k) clearance on 1994-11-30 under 510(k) number K944028. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCHEM CHEMISTRY ANALYZER?

PROCHEM CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1994-11-30. The listed applicant is Prisma Systems. The 510(k) number is K944028.

When did PROCHEM CHEMISTRY ANALYZER receive FDA 510(k) clearance?

PROCHEM CHEMISTRY ANALYZER received FDA 510(k) clearance on 1994-11-30, under 510(k) number K944028.

Who is the listed applicant for PROCHEM CHEMISTRY ANALYZER?

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 PROCHEM CHEMISTRY ANALYZER?

The FDA product code for PROCHEM CHEMISTRY ANALYZER is JJE.

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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: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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