MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

Prostate-specific Antigen (psa) For Management Of Prostate Cancers

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Modofication To Vitro Immunodiagnostic Products Psa Reagent Pack, Vitro Immunodiagnostic Products Psa Calibrators.

Pre-market Notification Details

• Device ID: K000566
• 510k Number: K000566
• Device Name: MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
• Classification: Prostate-specific Antigen (psa) For Management Of Prostate Cancers
• Applicant: Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101
• Contact: Joseph Falvo
• Correspondent: Joseph Falvo; Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101
• Product Code: LTJ
• CFR Regulation Number: 866.6010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-02-22
• Decision Date: 2000-03-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10758750001309	K000566	000
10758750000319	K000566	000