NGBClass II
Test, Glycosylated Hemoglobin, Over The Counter
Hematology · 21 CFR 864.7470
MDR events9All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
9 adverse event reports on file
- A1CNOW SELFCHECKMay 15, 2014MalfunctionBayer Healthcare Llc1826988-2014-00174
- A1CNOW SELFCHECKFeb 28, 2014MalfunctionBayer Healthcare Llc1826988-2014-00055
- A1CNOW SELFCHECKJan 27, 2014MalfunctionBayer Healthcare Llc1826988-2014-00017
- A1CNOW SELFCHECKJan 13, 2014MalfunctionBayer Healthcare Llc1826988-2013-00515
- A1CNOW SELFCHECKDec 5, 2013MalfunctionBayer Healthcare, Llc1826988-2013-00483
- A1CNOW SELFCHECKOct 11, 2013MalfunctionBayer Healthcare, Llc1826988-2013-00489
- A1CNOW SELFCHECKSep 16, 2013MalfunctionBayer Healthcare Llc1826988-2013-00456
- A1CNOW SELFCHECKSep 10, 2013MalfunctionBayer Healthcare Llc1826988-2013-00425
- A1CNOW SELFCHECKJul 31, 2013MalfunctionBayer Healthcare Llc1826988-2013-00363
Event type breakdown
Malfunction9
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.