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K Number
K000257
Device Name
IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6
Manufacturer
DIAGNOSTIC PRODUCTS CORP.
Date Cleared
2000-02-23

(27 days)

Product Code
JFH
Regulation Number
862.1020
Type
Traditional
Panel
IM
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.