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FDA 510(k)

VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT

K-Number: K940003 · 1995-10-19

ApplicantBuckman Co., Inc.
Decision Date1995-10-19
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1995-10-19 under 510(k) number K940003. 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 VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT?

VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT is a medical device that received FDA 510(k) clearance on 1995-10-19. The listed applicant is Buckman Co., Inc.. The 510(k) number is K940003.

When did VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT receive FDA 510(k) clearance?

VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT received FDA 510(k) clearance on 1995-10-19, under 510(k) number K940003.

Who is the listed applicant for VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT?

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

What is the FDA product code for VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT?

The FDA product code for VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT is GKZ.

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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.

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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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