ESTRADIOL KIT BY RIA

Radioimmunoassay, Estradiol

RADIOASSAY SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Estradiol Kit By Ria.

Pre-market Notification Details

• Device ID: K791652
• 510k Number: K791652
• Device Name: ESTRADIOL KIT BY RIA
• Classification: Radioimmunoassay, Estradiol
• Applicant: RADIOASSAY SYSTEMS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: CHP
• CFR Regulation Number: 862.1260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-08-21
• Decision Date: 1979-09-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817830023068	K791652	000
00817830023051	K791652	000
00817830023044	K791652	000
00817830023037	K791652	000