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FDA 510(k)

ADD OF RETICULOCYTE COUNT/CAPABILITIES

K-Number: K800533 · 1980-04-04

ApplicantAbbott Laboratories
Decision Date1980-04-04
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ADD OF RETICULOCYTE COUNT/CAPABILITIES is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1980-04-04 under 510(k) number K800533. 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 ADD OF RETICULOCYTE COUNT/CAPABILITIES?

ADD OF RETICULOCYTE COUNT/CAPABILITIES is a medical device that received FDA 510(k) clearance on 1980-04-04. The listed applicant is Abbott Laboratories. The 510(k) number is K800533.

When did ADD OF RETICULOCYTE COUNT/CAPABILITIES receive FDA 510(k) clearance?

ADD OF RETICULOCYTE COUNT/CAPABILITIES received FDA 510(k) clearance on 1980-04-04, under 510(k) number K800533.

Who is the listed applicant for ADD OF RETICULOCYTE COUNT/CAPABILITIES?

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 ADD OF RETICULOCYTE COUNT/CAPABILITIES?

The FDA product code for ADD OF RETICULOCYTE COUNT/CAPABILITIES is 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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