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FDA 510(k)

TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS

K-Number: K970836 · 1997-08-26

ApplicantBecton Dickinson Immunocytometry Systems
Decision Date1997-08-26
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Immunocytometry Systems. It received FDA 510(k) clearance on 1997-08-26 under 510(k) number K970836. 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 TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS?

TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS is a medical device that received FDA 510(k) clearance on 1997-08-26. The listed applicant is Becton Dickinson Immunocytometry Systems. The 510(k) number is K970836.

When did TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS receive FDA 510(k) clearance?

TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS received FDA 510(k) clearance on 1997-08-26, under 510(k) number K970836.

Who is the listed applicant for TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS?

The FDA 510(k) record lists Becton Dickinson Immunocytometry Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS?

The FDA product code for TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS is GKZ.

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Other records listing Becton Dickinson Immunocytometry Systems as applicant

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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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