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FDA 510(k)

COULTER MULTI-Q-PREP

K-Number: K923530 · 1992-10-14

ApplicantCoulter Electronics, Inc.
Decision Date1992-10-14
Product CodeGKH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER MULTI-Q-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 1992-10-14 under 510(k) number K923530. The device is classified under product code GKH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER MULTI-Q-PREP?

COULTER MULTI-Q-PREP is a medical device that received FDA 510(k) clearance on 1992-10-14. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K923530.

When did COULTER MULTI-Q-PREP receive FDA 510(k) clearance?

COULTER MULTI-Q-PREP received FDA 510(k) clearance on 1992-10-14, under 510(k) number K923530.

Who is the listed applicant for COULTER MULTI-Q-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 COULTER MULTI-Q-PREP?

The FDA product code for COULTER MULTI-Q-PREP is GKH.

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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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADERK921567COULTER MH017

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Related Devices (Code: GKH)

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.

K100684CELLTRACKS AUTOPREP SYSTEM MODEL:9541Veridex, LLCK040077IMMUNICON CELLTRACKS AUTOPREP SYSTEMImmunicon Corp.K022512CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518Immunicon Corp.K021150COULTER CELLPREPBeckman Coulter, Inc.K935953COULTER MULTI Q PREPCoulter Corp.K904795FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic

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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