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FDA 510(k)

IMS HEMATOLOGY MIXER

K-Number: K823124 · 1982-11-22

ApplicantInnovative Medical Systems, Inc.
Decision Date1982-11-22
Product CodeGLE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMS HEMATOLOGY MIXER is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Medical Systems, Inc.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K823124. 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 IMS HEMATOLOGY MIXER?

IMS HEMATOLOGY MIXER is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Innovative Medical Systems, Inc.. The 510(k) number is K823124.

When did IMS HEMATOLOGY MIXER receive FDA 510(k) clearance?

IMS HEMATOLOGY MIXER received FDA 510(k) clearance on 1982-11-22, under 510(k) number K823124.

Who is the listed applicant for IMS HEMATOLOGY MIXER?

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

What is the FDA product code for IMS HEMATOLOGY MIXER?

The FDA product code for IMS HEMATOLOGY MIXER is GLE.

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Other records listing Innovative Medical Systems, Inc. as applicant

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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.

K800003CORTEX DOUBLE HELIX SAMPLERCortex Research Corp.K780544DISC-PAK ROTATORTechhnilab Instruments, Inc.K771617SPECI-MIXThermolyne Corp.K770830PLATELET AGITATORHelmer Labs, Inc.

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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