MAGNESIUM

Photometric Method, Magnesium

POINTE SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Magnesium.

Pre-market Notification Details

• Device ID: K853592
• 510k Number: K853592
• Device Name: MAGNESIUM
• Classification: Photometric Method, Magnesium
• Applicant: POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224
• Contact: Janusz M Szyszko
• Correspondent: Janusz M Szyszko; POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224
• Product Code: JGJ
• CFR Regulation Number: 862.1495 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-08-27
• Decision Date: 1985-09-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811727015099	K853592	000
00811727016232	K853592	000
00817274022405	K853592	000
00817439021106	K853592	000
00817439021120	K853592	000
00811727011879	K853592	000
00811727012746	K853592	000
00811727013088	K853592	000
00811727013361	K853592	000
00811727013606	K853592	000
00811727014788	K853592	000
00811727014795	K853592	000
00811727014801	K853592	000
00811727015938	K853592	000