ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953

Radioimmunoassay, Parathyroid Hormone

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Intact Pth And Calibrators, Models A 16972 And A 16953.

Pre-market Notification Details

• Device ID: K061190
• 510k Number: K061190
• Device Name: ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
• Classification: Radioimmunoassay, Parathyroid Hormone
• Applicant: BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084
• Contact: Valynda L Machen
• Correspondent: Valynda L Machen; BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084
• Product Code: CEW
• CFR Regulation Number: 862.1545 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-04-28
• Decision Date: 2006-09-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590201937	K061190	000
15099590201920	K061190	000