510(k) K132751 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
MULTICHEM S PLUS / S PLUS (ASSAYED)
| Applicant | Techno-Path Manufacturing , Ltd., Highland Village TX, US |
| Decision | Substantially Equivalent, Oct 22, 2013 |
| Received | Sep 3, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K132751
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2019 | Abbott Laboratories Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for th Terminated |
JJY | None listed |
| Apr 9, 2019 | Abbott Laboratories Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for th Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.