510(k) K081938 ยท LDP Colorimetry, Acetaminophen
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
| Applicant | Genzyme Diagnostics P.E.I., Inc., Charlottetown, Prin Ed Island, CA |
| Decision | Substantially Equivalent, May 1, 2009 |
| Received | Jul 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081938
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2017 | Beckman Coulter Inc. Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. U Terminated |
LDP | None listed |
| Jan 22, 2016 | Sekisui Diagnostics P.E.I. Inc. Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic
Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml
Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml
In-Vitro quant Terminated |
LDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.