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FDA 510(k)

COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.

K-Number: K874838 · 1988-02-19

Decision Date1988-02-19
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. 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 1988-02-19 under 510(k) number K874838. 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 COUNTER MODEL T SERIES W/2-PART DIFFERENT.?

COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. is a medical device that received FDA 510(k) clearance on 1988-02-19. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K874838.

When did COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. receive FDA 510(k) clearance?

COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. received FDA 510(k) clearance on 1988-02-19, under 510(k) number K874838.

Who is the listed applicant for COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.?

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 COUNTER MODEL T SERIES W/2-PART DIFFERENT.?

The FDA product code for COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. is GKZ.

Related Clinical Trials

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.

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.

View all 101 devices →

Related Devices (Code: GKZ)

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.

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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