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FDA 510(k)

CUTTER/COMPUR MINI CENTRIFUGE

K-Number: K781059 · 1978-08-14

ApplicantCutter Laboratories, Inc.
Decision Date1978-08-14
Product CodeGKF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CUTTER/COMPUR MINI CENTRIFUGE is the device name listed in this FDA 510(k) record. The listed applicant is Cutter Laboratories, Inc.. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K781059. 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 CUTTER/COMPUR MINI CENTRIFUGE?

CUTTER/COMPUR MINI CENTRIFUGE is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Cutter Laboratories, Inc.. The 510(k) number is K781059.

When did CUTTER/COMPUR MINI CENTRIFUGE receive FDA 510(k) clearance?

CUTTER/COMPUR MINI CENTRIFUGE received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781059.

Who is the listed applicant for CUTTER/COMPUR MINI CENTRIFUGE?

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

What is the FDA product code for CUTTER/COMPUR MINI CENTRIFUGE?

The FDA product code for CUTTER/COMPUR MINI CENTRIFUGE is GKF.

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Other records listing Cutter Laboratories, Inc. as applicant

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Related Devices (Code: GKF)

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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

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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