510(k) K911141 ยท CGA Glucose Oxidase, Glucose
HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER
| Applicant | Hemocue, Inc., Potomac MD, US |
| Decision | Substantially Equivalent, May 8, 1991 |
| Received | Mar 14, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911141
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE. Open, Classified |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.