VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS

Multi-analyte Controls, All Kinds (assayed)

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic Products Anemia Controls.

Pre-market Notification Details

• Device ID: K990016
• 510k Number: K990016
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101
• Contact: Anne Zavertnik
• Correspondent: Anne Zavertnik; Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101
• Product Code: JJY
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-01-04
• Decision Date: 1999-05-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10758750009411	K990016	000