TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013

Radioimmunoassay, Parathyroid Hormone

SCANTIBODIES LABORATORY, INC.

The following data is part of a premarket notification filed by Scantibodies Laboratory, Inc. with the FDA for Total Intact Pth Immunoradiometric Assay (coated Tube Version), Model 3kg013.

Pre-market Notification Details

• Device ID: K051888
• 510k Number: K051888
• Device Name: TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
• Classification: Radioimmunoassay, Parathyroid Hormone
• Applicant: SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071
• Contact: Michael Nordstrom
• Correspondent: Michael Nordstrom; SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071
• Product Code: CEW
• CFR Regulation Number: 862.1545 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-07-12
• Decision Date: 2005-10-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850002253139	K051888	000