FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY

Photometric Method, Iron (non-heme)

POINTE SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Ferrozine (colorimetric) Iron Binding Capacity.

Pre-market Notification Details

• Device ID: K864882
• 510k Number: K864882
• Device Name: FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
• Classification: Photometric Method, Iron (non-heme)
• Applicant: POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224
• Contact: William F Walters
• Correspondent: William F Walters; POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224
• Product Code: JIY
• CFR Regulation Number: 862.1410 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-12-12
• Decision Date: 1987-01-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811727015068	K864882	000
00811727016188	K864882	000
00817274021781	K864882	000
00817274022245	K864882	000
00817274022580	K864882	000
00817439020932	K864882	000
00817439020956	K864882	000
00811727011589	K864882	000
00811727011596	K864882	000
00811727011602	K864882	000
00811727011619	K864882	000
00811727011626	K864882	000
00811727011633	K864882	000
00811727013590	K864882	000
00811727014764	K864882	000
00811727015884	K864882	000