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FDA 510(k)

PLATELET AGITATOR

K-Number: K812533 · 1981-09-29

ApplicantHelmer Labs, Inc.
Decision Date1981-09-29
Product CodeKSQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET AGITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Helmer Labs, Inc.. It received FDA 510(k) clearance on 1981-09-29 under 510(k) number K812533. The device is classified under product code KSQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET AGITATOR?

PLATELET AGITATOR is a medical device that received FDA 510(k) clearance on 1981-09-29. The listed applicant is Helmer Labs, Inc.. The 510(k) number is K812533.

When did PLATELET AGITATOR receive FDA 510(k) clearance?

PLATELET AGITATOR received FDA 510(k) clearance on 1981-09-29, under 510(k) number K812533.

Who is the listed applicant for PLATELET AGITATOR?

The FDA 510(k) record lists Helmer Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLATELET AGITATOR?

The FDA product code for PLATELET AGITATOR is KSQ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Helmer Labs, Inc. 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.

K802608HEMATIC BLOOD MIXERK770830PLATELET AGITATOR

Related Devices (Code: KSQ)

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.

K842746HYCEL ROTOR-MIXER AND/OR MULTIR&D Systems, Inc.K820712SEPCOR UNIT COLLECTION MONITORSeparation Science Corp.K810617MOBILE MATIC AUTOMATIC DONOR SCALELifeline Instruments, Inc.K802608HEMATIC BLOOD MIXERHelmer Labs, Inc.K800104ROYCO MODEL 951 CELL MIXERRoyco InstrumentsK780189PLATELET ROTATORTravenol 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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