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FDA 510(k)

SPECI-MIX

K-Number: K771617 · 1977-09-02

ApplicantThermolyne Corp.
Decision Date1977-09-02
Product CodeGLE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPECI-MIX is the device name listed in this FDA 510(k) record. The listed applicant is Thermolyne Corp.. It received FDA 510(k) clearance on 1977-09-02 under 510(k) number K771617. 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 SPECI-MIX?

SPECI-MIX is a medical device that received FDA 510(k) clearance on 1977-09-02. The listed applicant is Thermolyne Corp.. The 510(k) number is K771617.

When did SPECI-MIX receive FDA 510(k) clearance?

SPECI-MIX received FDA 510(k) clearance on 1977-09-02, under 510(k) number K771617.

Who is the listed applicant for SPECI-MIX?

The FDA 510(k) record lists Thermolyne Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECI-MIX?

The FDA product code for SPECI-MIX 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 Thermolyne 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.

K792095HISTO-CENTER IIK770914INCUBATOR, PORTABLE, ACT-STATK760928BLOOD BANK DRI-BATH

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.K770830PLATELET AGITATORHelmer Labs, Inc.

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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