Company
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2018 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only Terminated |
GKA | None listed |
| Nov 1, 2018 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. Terminated |
GKA | None listed |
| Nov 1, 2018 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. Terminated |
GKA | None listed |
| Nov 1, 2018 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use on Terminated |
GKA | None listed |
| Nov 1, 2018 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic Terminated |
GKA | None listed |
| Sep 12, 2016 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD Terminated |
PCL | K140455 |
| Dec 16, 2014 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for th Terminated |
LIP | K904524 |
| Dec 26, 2013 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Captia Syphilis-G Test Kit
Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponem Terminated |
LIP | None listed |
| Sep 24, 2012 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests.
For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antib Terminated |
GQX | K883427 |