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FDA 510(k)

AUTOMATED BLOOD CELL SEPARATOR

K-Number: K830831 · 1983-06-16

ApplicantCryosan, Inc.
Decision Date1983-06-16
Product CodeLKN
DecisionSubstantially Equivalent

Device Summary

AUTOMATED BLOOD CELL SEPARATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cryosan, Inc.. It received FDA 510(k) clearance on 1983-06-16 under 510(k) number K830831. The device is classified under product code LKN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED BLOOD CELL SEPARATOR?

AUTOMATED BLOOD CELL SEPARATOR is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Cryosan, Inc.. The 510(k) number is K830831.

When did AUTOMATED BLOOD CELL SEPARATOR receive FDA 510(k) clearance?

AUTOMATED BLOOD CELL SEPARATOR received FDA 510(k) clearance on 1983-06-16, under 510(k) number K830831.

Who is the listed applicant for AUTOMATED BLOOD CELL SEPARATOR?

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

What is the FDA product code for AUTOMATED BLOOD CELL SEPARATOR?

The FDA product code for AUTOMATED BLOOD CELL SEPARATOR is LKN.

Related Clinical Trials

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.

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Other records listing Cryosan, Inc. 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.

K831953INFUSION PUMPK822521AUTOMATED BLOOD CELL SEPARATORK813489ROCKING/CIRCULATING CYTO-THERM II 3570K812309CRYOSAN NORMAL SALINEK812311CIRCULATING CYTO-THERMS

Related Devices (Code: LKN)

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.

K192150AMICUS Separator SystemFresenius Kabi AGK183081Spectra Optia Apheresis SystemTerumobct, Inc.K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,LlcK181049Spectra Optia Apheresis SystemTerumobct, Inc.K172590Spectra Optia Apheresis SystemTerumobct, Inc.K153601Spectra Optia Apheresis SystemTerumobct, Inc.

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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