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FDA 510(k)

E-Z PREP

K-Number: K831558 · 1983-06-16

ApplicantCoulter Electronics, Inc.
Decision Date1983-06-16
Product CodeGKJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

E-Z PREP is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1983-06-16 under 510(k) number K831558. 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 E-Z PREP?

E-Z PREP is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K831558.

When did E-Z PREP receive FDA 510(k) clearance?

E-Z PREP received FDA 510(k) clearance on 1983-06-16, under 510(k) number K831558.

Who is the listed applicant for E-Z PREP?

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

What is the FDA product code for E-Z PREP?

The FDA product code for E-Z PREP is GKJ.

Other records listing Coulter Electronics, Inc. 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.

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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.K854121MICRO-MAT SYSTEMPrevo Micro-Mat SystemK811534HEMASPINNERGeometric Data, Div. Smithkline Corp.K771898AUTOMATED SLIDE SPINNERDynatech Cryomedical Co.K760007BLOOD-SMEARING INSTRUMENT (MINIPREP TM)Geometric Data, Div. Smithkline Corp.

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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