510(k) K942458 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, Mar 13, 1995 |
| Received | May 24, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942458
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2019 | Randox Laboratories, Limited Human Assayed Multi-Sera Level 2, Model NO. HN1530
Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is f Terminated |
JJY | None listed |
| Sep 15, 2015 | MedtestDx, Inc. MedTest DX Control Reconstitution Fluid
Kit configuration: 20 x 5 ml.
Bottle: 5 ml amber glass
Cap: 18 mm white seal plug seal rubber
HC-DIL (Human Control Diluent) is reagent grade water filled in Terminated |
JJY | None listed |
| Oct 23, 2014 | Medtest Holdings, Inc. MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200)
HEC200
" Sml amber glass vial with rubber stopper and black plastic screw cap.
" 1 0 control vials per box, 12 ce Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.