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FDA 510(k)

ALPHA MICRON 20/40 MICROAGGREGATE FILTER

K-Number: K970225 · 1997-02-14

ApplicantAlpha Therapeutic Corp.
Decision Date1997-02-14
Product CodeCAK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALPHA MICRON 20/40 MICROAGGREGATE FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Therapeutic Corp.. It received FDA 510(k) clearance on 1997-02-14 under 510(k) number K970225. The device is classified under product code CAK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA MICRON 20/40 MICROAGGREGATE FILTER?

ALPHA MICRON 20/40 MICROAGGREGATE FILTER is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is Alpha Therapeutic Corp.. The 510(k) number is K970225.

When did ALPHA MICRON 20/40 MICROAGGREGATE FILTER receive FDA 510(k) clearance?

ALPHA MICRON 20/40 MICROAGGREGATE FILTER received FDA 510(k) clearance on 1997-02-14, under 510(k) number K970225.

Who is the listed applicant for ALPHA MICRON 20/40 MICROAGGREGATE FILTER?

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

What is the FDA product code for ALPHA MICRON 20/40 MICROAGGREGATE FILTER?

The FDA product code for ALPHA MICRON 20/40 MICROAGGREGATE FILTER is CAK.

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Other records listing Alpha Therapeutic 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.

K955515ALPHA MICRON 20 MICROAGGREGATE FILTERK854920THERAPY CASSETTSK854441STUART GILMAN'S WEIGHT LOSS PLANK833294ALPHA Y-RECIPIENT SETK820447ALPHA PLASMA TRANSFER SETK810897ALPHA PLASTIC PLASMA BOTTLE

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Related Devices (Code: CAK)

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.

K061103HAEMONETICS 40U RBC FILTER BAGHaemonetics Corp.K022477SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SETSummit Medical , Ltd.K000719NEOCARE 20 MICRON BLOOD FILTERWhatman, Inc.K990310CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)Charter Medical, Ltd.K982822FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72Baxter Healthcare CorpK972159FENWAL 40 MICRON TRANSFUSION FILTERBaxter Healthcare Corp

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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