510(k) K090413 ยท LCP Assay, Glycosylated Hemoglobin
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
| Applicant | Bayer Healthcare, LLC, Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 14, 2009 |
| Received | Feb 18, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090413
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2024 | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collect Completed |
LCP | None listed |
| Dec 2, 2016 | Polymer Technology Systems A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024;
EU: 3037, 3038, 3057, 3058 Terminated |
LCP | None listed |
| Dec 2, 2016 | Polymer Technology Systems A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062 Terminated |
LCP | None listed |
| Dec 2, 2016 | Polymer Technology Systems Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 Terminated |
LCP | None listed |
| Dec 2, 2016 | Polymer Technology Systems ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 Terminated |
LCP | None listed |
| Dec 2, 2016 | Polymer Technology Systems CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 Terminated |
LCP | None listed |
| Nov 2, 2013 | Bayer Healthcare Llc Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by
Bayer HealthCare LLC Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.