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FDA 510(k)

HEMATIC BLOOD MIXER

K-Number: K802608 · 1980-12-11

ApplicantHelmer Labs, Inc.
Decision Date1980-12-11
Product CodeKSQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATIC BLOOD MIXER 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 1980-12-11 under 510(k) number K802608. 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 HEMATIC BLOOD MIXER?

HEMATIC BLOOD MIXER is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Helmer Labs, Inc.. The 510(k) number is K802608.

When did HEMATIC BLOOD MIXER receive FDA 510(k) clearance?

HEMATIC BLOOD MIXER received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802608.

Who is the listed applicant for HEMATIC BLOOD MIXER?

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 HEMATIC BLOOD MIXER?

The FDA product code for HEMATIC BLOOD MIXER 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.

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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.

K812533PLATELET AGITATORK770830PLATELET 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.K812533PLATELET AGITATORHelmer Labs, Inc.K810617MOBILE MATIC AUTOMATIC DONOR SCALELifeline Instruments, 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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