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K Number
K963640
Device Name
OLYMPUS ACID PHOSPHATASE REAGENT
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
1997-02-18

(159 days)

Product Code
CKB
Regulation Number
862.1020
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 862.1020 Acid phosphatase (total or prostatic) test system.

(a)
Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.