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FDA 510(k)

PLATELET AGITATOR

K-Number: K770830 · 1977-07-11

ApplicantHelmer Labs, Inc.
Decision Date1977-07-11
Product CodeGLE
Advisory CommitteeCH
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 1977-07-11 under 510(k) number K770830. The device is classified under product code GLE. It was reviewed by the CH 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 1977-07-11. The listed applicant is Helmer Labs, Inc.. The 510(k) number is K770830.

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

PLATELET AGITATOR received FDA 510(k) clearance on 1977-07-11, under 510(k) number K770830.

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 GLE.

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 AGITATORK802608HEMATIC BLOOD MIXER

Related Devices (Code: GLE)

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.

K823124IMS HEMATOLOGY MIXERInnovative Medical Systems, Inc.K800003CORTEX DOUBLE HELIX SAMPLERCortex Research Corp.K780544DISC-PAK ROTATORTechhnilab Instruments, Inc.K771617SPECI-MIXThermolyne Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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