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FDA 510(k)

ALPHA PLASTIC PLASMA BOTTLE

K-Number: K810897 · 1981-09-23

ApplicantAlpha Therapeutic Corp.
Decision Date1981-09-23
Product CodeKSR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ALPHA PLASTIC PLASMA BOTTLE 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 1981-09-23 under 510(k) number K810897. The device is classified under product code KSR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA PLASTIC PLASMA BOTTLE?

ALPHA PLASTIC PLASMA BOTTLE is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Alpha Therapeutic Corp.. The 510(k) number is K810897.

When did ALPHA PLASTIC PLASMA BOTTLE receive FDA 510(k) clearance?

ALPHA PLASTIC PLASMA BOTTLE received FDA 510(k) clearance on 1981-09-23, under 510(k) number K810897.

Who is the listed applicant for ALPHA PLASTIC PLASMA BOTTLE?

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 PLASTIC PLASMA BOTTLE?

The FDA product code for ALPHA PLASTIC PLASMA BOTTLE is KSR.

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 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.

K970225ALPHA MICRON 20/40 MICROAGGREGATE FILTERK955515ALPHA MICRON 20 MICROAGGREGATE FILTERK854920THERAPY CASSETTSK854441STUART GILMAN'S WEIGHT LOSS PLANK833294ALPHA Y-RECIPIENT SETK820447ALPHA PLASMA TRANSFER SET

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Related Devices (Code: KSR)

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.

K032827KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501Tyco HealthcareK020753DEROYAL SURGICAL, UMBILICUPDeroyalK810500BLOOD FREEZING BAGDelmed, Inc.K811523PLASMA FLEXTerumo America, Inc.K811449HAEMONETICS 1000ML COMPONENT BAGHaemonetics Corp.K810711HAEMONETICS 600 ML. COMPONENT BAGHaemonetics 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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