510(k) K083222 ยท LPS Urinary Homocystine (Nonquantitative) Test System
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Jul 31, 2009 |
| Received | Nov 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083222
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2019 | Axis-Shield Diagnostics, Ltd. Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinem Open, Classified |
LPS | None listed |
| Sep 16, 2019 | Axis-Shield Diagnostics, Ltd. Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteine Open, Classified |
LPS | None listed |
| Sep 16, 2019 | Axis-Shield Diagnostics, Ltd. Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocystein Open, Classified |
LPS | None listed |
| Jul 1, 2015 | Axis-Shield Diagnostics, Ltd. Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on th Terminated |
LPS | None listed |
| Apr 3, 2015 | Medtest Holdings, Inc. Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of ca Terminated |
LPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.