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FDA 510(k)

AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR

K-Number: K820396 · 1982-04-27

ApplicantPheragen Technology Corp.
Decision Date1982-04-27
Product CodeGKT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR is the device name listed in this FDA 510(k) record. The listed applicant is Pheragen Technology Corp.. It received FDA 510(k) clearance on 1982-04-27 under 510(k) number K820396. 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 AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR?

AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR is a medical device that received FDA 510(k) clearance on 1982-04-27. The listed applicant is Pheragen Technology Corp.. The 510(k) number is K820396.

When did AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR receive FDA 510(k) clearance?

AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR received FDA 510(k) clearance on 1982-04-27, under 510(k) number K820396.

Who is the listed applicant for AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR?

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

What is the FDA product code for AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR?

The FDA product code for AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR is GKT.

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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.K801233CELLTRIFUGE IITravenol Laboratories, S.A.K791106STERILE, DISPOSABLE CENTRIFUGE BOWLTravenol Laboratories, S.A.K790105TERUMO IMUGARDTerumo America, 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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