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FDA 510(k)

PRISMA

K-Number: K791297 · 1979-08-10

ApplicantLkb Instruments, Inc.
Decision Date1979-08-10
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRISMA is the device name listed in this FDA 510(k) record. The listed applicant is Lkb Instruments, Inc.. It received FDA 510(k) clearance on 1979-08-10 under 510(k) number K791297. 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 PRISMA?

PRISMA is a medical device that received FDA 510(k) clearance on 1979-08-10. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K791297.

When did PRISMA receive FDA 510(k) clearance?

PRISMA received FDA 510(k) clearance on 1979-08-10, under 510(k) number K791297.

Who is the listed applicant for PRISMA?

The FDA 510(k) record lists Lkb Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRISMA?

The FDA product code for PRISMA is JJE.

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Related PubMed Literature

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PMID: 41827353Clinical Trial Design and Regulatory Requirements for Artificial Intelligence as a Medical Device: A PRISMA-ScR-Guided Scoping Review of Global Guidance and Evidence (2017-2025).Journal of clinical medicine ()

Other records listing Lkb Instruments, Inc. as applicant

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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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