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FDA 510(k)

CD8 CYTOSPHERES KIT

K-Number: K923951 · 1994-04-25

ApplicantCoulter Electronics, Inc.
Decision Date1994-04-25
Product CodeMAM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CD8 CYTOSPHERES KIT 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 1994-04-25 under 510(k) number K923951. The device is classified under product code MAM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CD8 CYTOSPHERES KIT?

CD8 CYTOSPHERES KIT is a medical device that received FDA 510(k) clearance on 1994-04-25. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K923951.

When did CD8 CYTOSPHERES KIT receive FDA 510(k) clearance?

CD8 CYTOSPHERES KIT received FDA 510(k) clearance on 1994-04-25, under 510(k) number K923951.

Who is the listed applicant for CD8 CYTOSPHERES KIT?

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 CD8 CYTOSPHERES KIT?

The FDA product code for CD8 CYTOSPHERES KIT is MAM.

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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.

K930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADERK921567COULTER MH017

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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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