510(k) K982071 ยท KHP Acid, Lactic, Enzymatic Method
I-STAT LACTATE TEST
| Applicant | I-Stat Corp., Princeton NJ, US |
| Decision | Substantially Equivalent, Jun 29, 1998 |
| Received | Jun 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982071
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2025 | Abbott Point Of Care Inc. i-STAT CG4+ cartridge (white). List Number: 03P85-25. Open, Classified |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.