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FDA 510(k)

TITERTEK DULUTER/DISPENSER 78-640-00

K-Number: K844568 · 1985-01-30

Decision Date1985-01-30
Product CodeJTC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TITERTEK DULUTER/DISPENSER 78-640-00 is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1985-01-30 under 510(k) number K844568. The device is classified under product code JTC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITERTEK DULUTER/DISPENSER 78-640-00?

TITERTEK DULUTER/DISPENSER 78-640-00 is a medical device that received FDA 510(k) clearance on 1985-01-30. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K844568.

When did TITERTEK DULUTER/DISPENSER 78-640-00 receive FDA 510(k) clearance?

TITERTEK DULUTER/DISPENSER 78-640-00 received FDA 510(k) clearance on 1985-01-30, under 510(k) number K844568.

Who is the listed applicant for TITERTEK DULUTER/DISPENSER 78-640-00?

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

What is the FDA product code for TITERTEK DULUTER/DISPENSER 78-640-00?

The FDA product code for TITERTEK DULUTER/DISPENSER 78-640-00 is JTC.

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.

Other records listing Flow Laboratories, 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.

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Related Devices (Code: JTC)

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.

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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