A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC

Assay, Glycosylated Hemoglobin

BAYER HEALTHCARE, LLC

The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for A1cnow+ (10 Test Kit, Professional Use) Model 3024, A1cnow+(20 Test Kit, Professional Use) Model 3021, A1cnow Self Chec.

Pre-market Notification Details

• Device ID: K090413
• 510k Number: K090413
• Device Name: A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
• Classification: Assay, Glycosylated Hemoglobin
• Applicant: BAYER HEALTHCARE, LLC 510 OAKMEAD PKWY. Sunnyvale, CA 94085
• Contact: Cathy Peters
• Correspondent: Cathy Peters; BAYER HEALTHCARE, LLC 510 OAKMEAD PKWY. Sunnyvale, CA 94085
• Product Code: LCP
• CFR Regulation Number: 864.7470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-18
• Decision Date: 2009-05-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00381933070019	K090413	000
10021292015029	K090413	000
00681131403252	K090413	000
00817643020223	K090413	000
00050428350423	K090413	000
00050428526859	K090413	000
00681131078368	K090413	000
00311917169835	K090413	000
00381933021011	K090413	000
00381933024012	K090413	000
00381933030013	K090413	000
10381933080015	K090413	000