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FDA 510(k)

MICROHEMATOCRIT CENTRIFUGE

K-Number: K864039 · 1986-10-29

ApplicantPlaza Medical, Inc.
Decision Date1986-10-29
Product CodeGKF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MICROHEMATOCRIT CENTRIFUGE is the device name listed in this FDA 510(k) record. The listed applicant is Plaza Medical, Inc.. It received FDA 510(k) clearance on 1986-10-29 under 510(k) number K864039. The device is classified under product code GKF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROHEMATOCRIT CENTRIFUGE?

MICROHEMATOCRIT CENTRIFUGE is a medical device that received FDA 510(k) clearance on 1986-10-29. The listed applicant is Plaza Medical, Inc.. The 510(k) number is K864039.

When did MICROHEMATOCRIT CENTRIFUGE receive FDA 510(k) clearance?

MICROHEMATOCRIT CENTRIFUGE received FDA 510(k) clearance on 1986-10-29, under 510(k) number K864039.

Who is the listed applicant for MICROHEMATOCRIT CENTRIFUGE?

The FDA 510(k) record lists Plaza Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROHEMATOCRIT CENTRIFUGE?

The FDA product code for MICROHEMATOCRIT CENTRIFUGE is GKF.

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Related Devices (Code: GKF)

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.

K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)Instrumentation Laboratory COK983551CRIT-SCAN II MONITORIn-Line Diagnostics Corp.K981427STAT PROFILE M ANALYZERNova Biomedical Corp.K981425STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERSNova Biomedical Corp.K981426STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERSNova Biomedical Corp.K953519MICROSPIN 24Vulcon Technologies

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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