510(k) K071277 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 1, 2007 |
| Received | May 7, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2017 | Beckman Coulter Inc Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288
Product Usage:
Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems. Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.