Technicon Chem 1 System Acid Phosphatase (Total)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K884747 ↗

FDA Product Code

CKB

Device Class

Class II

Regulation

21 CFR Part 862.1020

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the intended use of the Technicon Chem 1 System Acid Phosphatase (Total)?

  This device is an acid phosphatase test system specifically intended for the measurement of acid phosphatase enzyme activity within human plasma and serum samples.

• What is the regulatory status of this device?

  The Technicon Chem 1 System Acid Phosphatase (Total) is a Class II medical device that has received FDA 510(k) clearance under the number K884747, confirming it is substantially equivalent to legally marketed predicate devices.

• Under which medical specialty is this device categorized?

  This device is categorized under the Clinical Chemistry medical specialty, as it is designed to perform quantitative enzymatic analysis on clinical laboratory specimens.