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FDA 510(k)

DISC-PAK ROTATOR

K-Number: K780544 · 1978-04-24

ApplicantTechhnilab Instruments, Inc.
Decision Date1978-04-24
Product CodeGLE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DISC-PAK ROTATOR is the device name listed in this FDA 510(k) record. The listed applicant is Techhnilab Instruments, Inc.. It received FDA 510(k) clearance on 1978-04-24 under 510(k) number K780544. 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 DISC-PAK ROTATOR?

DISC-PAK ROTATOR is a medical device that received FDA 510(k) clearance on 1978-04-24. The listed applicant is Techhnilab Instruments, Inc.. The 510(k) number is K780544.

When did DISC-PAK ROTATOR receive FDA 510(k) clearance?

DISC-PAK ROTATOR received FDA 510(k) clearance on 1978-04-24, under 510(k) number K780544.

Who is the listed applicant for DISC-PAK ROTATOR?

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

What is the FDA product code for DISC-PAK ROTATOR?

The FDA product code for DISC-PAK ROTATOR is GLE.

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Other records listing Techhnilab Instruments, 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.

K813523ELECTRIC SELF STERILIZATION INOCUL. LOOPK780543THERMAJUST CIRCU-TEMPK771434MULTI-CAVITY EQUILIBRIUM CELLK770170MADDATHERM PARAFFIN BATHK770169BEESON AUTOMADDAK FEEDER

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.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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