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FDA 510(k)

BLOOD CELL SEPARATOR 2997

K-Number: K771258 · 1977-09-06

ApplicantIntl. Business Machines
Decision Date1977-09-06
Product CodeGKT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BLOOD CELL SEPARATOR 2997 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 1977-09-06 under 510(k) number K771258. The device is classified under product code GKT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD CELL SEPARATOR 2997?

BLOOD CELL SEPARATOR 2997 is a medical device that received FDA 510(k) clearance on 1977-09-06. The listed applicant is Intl. Business Machines. The 510(k) number is K771258.

When did BLOOD CELL SEPARATOR 2997 receive FDA 510(k) clearance?

BLOOD CELL SEPARATOR 2997 received FDA 510(k) clearance on 1977-09-06, under 510(k) number K771258.

Who is the listed applicant for BLOOD CELL SEPARATOR 2997?

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 BLOOD CELL SEPARATOR 2997?

The FDA product code for BLOOD CELL SEPARATOR 2997 is GKT.

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Other records listing Intl. Business Machines as applicant

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Related Devices (Code: GKT)

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.

K200530AMICUS Separator SystemFresenius Kabi AGK162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,LlcK822521AUTOMATED BLOOD CELL SEPARATORCryosan, Inc.K820396AUTOMATED BLOOD CELL SEPAR. DISP. SFTWRPheragen Technology Corp.K801233CELLTRIFUGE IITravenol Laboratories, S.A.K791106STERILE, DISPOSABLE CENTRIFUGE BOWLTravenol Laboratories, S.A.

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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