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FDA 510(k)

AUTO DIFFERENTIAL CELL COUNTER SYSTEM

K-Number: K770244 · 1977-08-04

ApplicantAbbott Laboratories
Decision Date1977-08-04
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTO DIFFERENTIAL CELL COUNTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1977-08-04 under 510(k) number K770244. 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 AUTO DIFFERENTIAL CELL COUNTER SYSTEM?

AUTO DIFFERENTIAL CELL COUNTER SYSTEM is a medical device that received FDA 510(k) clearance on 1977-08-04. The listed applicant is Abbott Laboratories. The 510(k) number is K770244.

When did AUTO DIFFERENTIAL CELL COUNTER SYSTEM receive FDA 510(k) clearance?

AUTO DIFFERENTIAL CELL COUNTER SYSTEM received FDA 510(k) clearance on 1977-08-04, under 510(k) number K770244.

Who is the listed applicant for AUTO DIFFERENTIAL CELL COUNTER SYSTEM?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO DIFFERENTIAL CELL COUNTER SYSTEM?

The FDA product code for AUTO DIFFERENTIAL CELL COUNTER SYSTEM 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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