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FDA 510(k)

COULTER MAXM W/ AUTOLOADER

K-Number: K922704 · 1992-07-27

ApplicantCoulter Electronics, Inc.
Decision Date1992-07-27
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER MAXM W/ AUTOLOADER 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 1992-07-27 under 510(k) number K922704. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER MAXM W/ AUTOLOADER?

COULTER MAXM W/ AUTOLOADER is a medical device that received FDA 510(k) clearance on 1992-07-27. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K922704.

When did COULTER MAXM W/ AUTOLOADER receive FDA 510(k) clearance?

COULTER MAXM W/ AUTOLOADER received FDA 510(k) clearance on 1992-07-27, under 510(k) number K922704.

Who is the listed applicant for COULTER MAXM W/ AUTOLOADER?

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 MAXM W/ AUTOLOADER?

The FDA product code for COULTER MAXM W/ AUTOLOADER is GKZ.

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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 KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K921567COULTER MH017

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Related Devices (Code: GKZ)

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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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