510(k) K972868 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
| Applicant | Bionostics, Inc., Acton MA, US |
| Decision | Substantially Equivalent, Aug 28, 1997 |
| Received | Aug 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972868
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mL Open, Classified |
JJY | None listed |
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Abbott Point of Care Control Control i-STAT Level 3 1.7 mL Open, Classified |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.