Product Classification

• Device: atomic absorption, calcium
• Regulation Description: Calcium test system.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: JFN
• Submission Type: 510(k)
• Regulation Number: 862.1145
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• NCCLS C31-A2 Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition (2001); ISBN 1-56238-436-8
• NCCLS C39-A A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard (2000) ISBN1-56238-398-1

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.