510(k) K895528 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 25, 1989 |
| Received | Sep 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895528
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2016 | Helena Laboratories, Inc. Gel Alkaline Phosphatase Isoenzyme Control Kit:
Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE
Gel Alkaline Phosphatase Isoenzyme Control 20mL 0018 Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.