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FDA 510(k)

RETICULOCYTE METHOD, RBC INDICES

K-Number: K954594 · 1996-08-23

ApplicantBayer Corp.
Decision Date1996-08-23
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RETICULOCYTE METHOD, RBC INDICES is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1996-08-23 under 510(k) number K954594. 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 RETICULOCYTE METHOD, RBC INDICES?

RETICULOCYTE METHOD, RBC INDICES is a medical device that received FDA 510(k) clearance on 1996-08-23. The listed applicant is Bayer Corp.. The 510(k) number is K954594.

When did RETICULOCYTE METHOD, RBC INDICES receive FDA 510(k) clearance?

RETICULOCYTE METHOD, RBC INDICES received FDA 510(k) clearance on 1996-08-23, under 510(k) number K954594.

Who is the listed applicant for RETICULOCYTE METHOD, RBC INDICES?

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

What is the FDA product code for RETICULOCYTE METHOD, RBC INDICES?

The FDA product code for RETICULOCYTE METHOD, RBC INDICES 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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