TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET

Calibrator, Secondary

REFERENCE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Reference Diagnostics, Inc. with the FDA for Total Iron-binding Capacity Calibrator Set. Direct Tibc Calibrator Set.

Pre-market Notification Details

• Device ID: K052148
• 510k Number: K052148
• Device Name: TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
• Classification: Calibrator, Secondary
• Applicant: REFERENCE DIAGNOSTICS, INC. 19 CROSBY DR. SUITE 30 Bedford, MA 01730
• Contact: Joseph Lawlor
• Correspondent: Joseph Lawlor; REFERENCE DIAGNOSTICS, INC. 19 CROSBY DR. SUITE 30 Bedford, MA 01730
• Product Code: JIT
• CFR Regulation Number: 862.1150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-08-08
• Decision Date: 2005-11-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811727011657	K052148	000
00817439021274	K052148	000
00845275003772	K052148	000