Discrete Photometric Chemistry Analyzer
by Hamilton Co. 510(k)
Active
510(k) K943493
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK943493 | Date30 Jan 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0103-2012
Certain lots of syringes have caused an increase in error message "DIS541", which indicates "improper dispensation".
Specification
- 510(k) Number
- FDA Product Code
- JJE
- Device Class
- Class I
- Regulation
- 21 CFR Part 862.2160
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent