510(k) K821982 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
TITAN GEL SERUM CONTROL
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 16, 1982 |
| Received | Jul 6, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821982
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2016 | Helena Laboratories, Inc. Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.