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FDA 510(k)

MICRO-MAT SYSTEM

K-Number: K854121 · 1985-10-31

ApplicantPrevo Micro-Mat System
Decision Date1985-10-31
Product CodeGKJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MICRO-MAT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Prevo Micro-Mat System. It received FDA 510(k) clearance on 1985-10-31 under 510(k) number K854121. The device is classified under product code GKJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-MAT SYSTEM?

MICRO-MAT SYSTEM is a medical device that received FDA 510(k) clearance on 1985-10-31. The listed applicant is Prevo Micro-Mat System. The 510(k) number is K854121.

When did MICRO-MAT SYSTEM receive FDA 510(k) clearance?

MICRO-MAT SYSTEM received FDA 510(k) clearance on 1985-10-31, under 510(k) number K854121.

Who is the listed applicant for MICRO-MAT SYSTEM?

The FDA 510(k) record lists Prevo Micro-Mat System as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO-MAT SYSTEM?

The FDA product code for MICRO-MAT SYSTEM is GKJ.

Related Clinical Trials

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Related Devices (Code: GKJ)

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.

K854962MICRO-MAT SYSTEMUlster Scientific, Inc.K831558E-Z PREPCoulter Electronics, Inc.K811534HEMASPINNERGeometric Data, Div. Smithkline Corp.K771898AUTOMATED SLIDE SPINNERDynatech Cryomedical Co.K760007BLOOD-SMEARING INSTRUMENT (MINIPREP TM)Geometric Data, Div. Smithkline Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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