Hemaflour ZP

FDA 510(k) K760506 · Buchler Instruments, Inc.

Substantially Equivalent

510(k) numberK760506

Submission

Device name
Hemaflour ZP
Applicant
Buchler Instruments, Inc.
Mchenry, IL, US
Received
August 23, 1976
Decision date
October 28, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KHO – Fluorometer, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2560
Specialty
Clinical Chemistry

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More from Tosoh Corp.

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Questions and answers

When was Hemaflour ZP cleared by the FDA?

Hemaflour ZP (K760506) received a 510(k) decision of Substantially Equivalent on October 28, 1976, 66 days after the submission was received.

What is the product code of K760506?

The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.