Recognized Consensus Standards

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New Search Back To Search Results Recognition List Number: 009 Publication Date: 03/08/2004  Part B: SUPPLEMENTARY INFORMATION Recognition Number 7-96: NCCLS EP18-A, Quality Management for Unit-Use Testing; Approved Guideline. (InVitro Diagnostics) Date of Standard: 2002.  Address of Standards Organization:   NATIONAL COMMITTEE FOR CLINICAL LABORATORY STANDARDS (NCCLS)   940 WEST VALLEY ROAD   SUITE 1400   WAYNE, PA 19087   CDRH Office and Division Associated with Recognized Standards: OFFICE OF IN VITRO DIAGNOSTIC DEVICE EVALUATION AND SAFETY (OIVD) DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD) Devices Affected: In Vitro Diagnostic Devices (IVDs) Processes Affected: IDE, 510(K), PMA, HDE, PDP Extent of Recognition: Complete standard Related CFR Citations and Product Codes: Relevant Guidance: Guidance for Over-the-counter Human Chorionic Gonadotropin (HCG) 510(k)s FDA Technical Contact:   Max Robinowitz, MD   FDA/CDRH/OIVD   2098 GAITHER ROAD, HFZ-440   ROCKVILLE, MD 20850   240/276-0493 ext: 136   Email: MYR@CDRH.FDA.GOV