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FDA 510(k)

UNIVERSAL CENTRIFUGE

K-Number: K822716 · 1982-09-30

ApplicantBiodynamics Corp.
Decision Date1982-09-30
Product CodeJPI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL CENTRIFUGE is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamics Corp.. It received FDA 510(k) clearance on 1982-09-30 under 510(k) number K822716. The device is classified under product code JPI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL CENTRIFUGE?

UNIVERSAL CENTRIFUGE is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Biodynamics Corp.. The 510(k) number is K822716.

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

UNIVERSAL CENTRIFUGE received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822716.

Who is the listed applicant for UNIVERSAL CENTRIFUGE?

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

What is the FDA product code for UNIVERSAL CENTRIFUGE?

The FDA product code for UNIVERSAL CENTRIFUGE is JPI.

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Other records listing Biodynamics Corp. as applicant

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.

K051675BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZERK884033BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZERK881631BIODYNAMICS AUTOTRANSFUSION RESERVOIRK881968BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZERK874361BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZERK873807AUTOTRANSFUSION APPARATUS

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Related Devices (Code: JPI)

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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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