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FDA 510(k)

ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)

K-Number: K761289 · 1977-03-28

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1977-03-28
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1977-03-28 under 510(k) number K761289. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)?

ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) is a medical device that received FDA 510(k) clearance on 1977-03-28. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K761289.

When did ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) receive FDA 510(k) clearance?

ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) received FDA 510(k) clearance on 1977-03-28, under 510(k) number K761289.

Who is the listed applicant for ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)?

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

What is the FDA product code for ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)?

The FDA product code for ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) is GKL.

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Related Devices (Code: GKL)

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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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