VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT

Radioimmunoassay, Parathyroid Hormone

ORTHO-CLINICAL DIAGNOSTICS

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Immunodiagnostics Products Intact Pth Reagent Pack, Vitros Immunodiagnostics Products Intact Pth Calibrators, Vit.

Pre-market Notification Details

• Device ID: K101921
• 510k Number: K101921
• Device Name: VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
• Classification: Radioimmunoassay, Parathyroid Hormone
• Applicant: ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DRIVE Rochester, NY 14626 -0551
• Contact: Declan Hynes
• Correspondent: Declan Hynes; ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DRIVE Rochester, NY 14626 -0551
• Product Code: CEW
• Subsequent Product Code: JIT
• Subsequent Product Code: JJX
• CFR Regulation Number: 862.1545 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-09
• Decision Date: 2010-10-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10758750006267	K101921	000
10758750006250	K101921	000
10758750006243	K101921	000
10758750006236	K101921	000