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FDA 510(k)

AUTOMATED 8400 BLOOD CELL SEPARATOR

K-Number: K831004 · 1983-09-12

ApplicantIntl. Business Machines
Decision Date1983-09-12
Product CodeLKN
DecisionSubstantially Equivalent

Device Summary

AUTOMATED 8400 BLOOD CELL SEPARATOR is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Business Machines. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831004. The device is classified under product code LKN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED 8400 BLOOD CELL SEPARATOR?

AUTOMATED 8400 BLOOD CELL SEPARATOR is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Intl. Business Machines. The 510(k) number is K831004.

When did AUTOMATED 8400 BLOOD CELL SEPARATOR receive FDA 510(k) clearance?

AUTOMATED 8400 BLOOD CELL SEPARATOR received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831004.

Who is the listed applicant for AUTOMATED 8400 BLOOD CELL SEPARATOR?

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

What is the FDA product code for AUTOMATED 8400 BLOOD CELL SEPARATOR?

The FDA product code for AUTOMATED 8400 BLOOD CELL SEPARATOR is LKN.

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Other records listing Intl. Business Machines 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.

K830163IBM 588 DIGITAL ECG ACQUISITION/ANALYSISK812355IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2K810989IBM 5880 ACQUISITION & ANALYSIS CART TELK810988IBM 5885 DIGITAL ECG ACQUISITION CARTK772353EKG ACQUISITION & ANALYSIS CARTK771258BLOOD CELL SEPARATOR 2997

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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

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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