TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600

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 Pth Immunoradiometric Assay(irma) Diagnostic Kit, Model 3kg600.

Pre-market Notification Details

• Device ID: K004038
• 510k Number: K004038
• Device Name: TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
• Classification: Radioimmunoassay, Parathyroid Hormone
• Applicant: SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071
• Contact: Richard Lenart
• Correspondent: Richard Lenart; SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY Santee, CA 92071
• Product Code: CEW
• Subsequent Product Code: JIS
• Subsequent Product Code: JJX
• CFR Regulation Number: 862.1545 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-12-28
• Decision Date: 2001-04-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850002253122	K004038	000