SURE CHECK OVULATION PREDICTOR

• K Number: K010244
• Device Name: SURE CHECK OVULATION PREDICTOR
• Manufacturer: Chembio Diagnostic Systems, Inc.
• Date Cleared: 2001-05-02 ( 97 days)
• Product Code: CEP
• Regulation Number: 862.1485
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 862.1485 Luteinizing hormone test system.

(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.