510(k) K041635 ยท LCP Assay, Glycosylated Hemoglobin
G5 I HBA1C TEST, G5 II HBA1C TEST
| Applicant | Provalis Diagnostics , Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Aug 16, 2004 |
| Received | Jun 16, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041635
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2010 | Bio-Rad Laboratories Inc in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer, manufactured by Bio-Rad, Flintshire, UK
The Terminated |
LCP | None listed |
| Oct 21, 2010 | Bio-Rad Laboratories Inc in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Labo Terminated |
LCP | None listed |
| Sep 23, 2008 | Cholestech Corp Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c). Terminated |
LCP | None listed |
| Nov 18, 2005 | Provalis Diagnostics Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.