SERIM LEUKOCYTE ESTERASE TEST STRIPS

• K Number: K000578
• Device Name: SERIM LEUKOCYTE ESTERASE TEST STRIPS
• Manufacturer: SERIM RESEARCH CORP.
• Date Cleared: 2000-05-05 ( 73 days)
• Product Code: LJX
• Regulation Number: 864.7675

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 864.7675 Leukocyte peroxidase test.

(a)
Identification. A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.(b)
Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Summary

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