The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Amm Cal, Bil Cal, Co2 Cal, Hdl Cal, Iron/mg Cal, Ldl Cal, Mc Cal, Upro Cal, And Ise Calibrator Levels 1 And 2.
| Device ID | K981706 |
| 510k Number | K981706 |
| Device Name: | AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Contact | Mark Littlefield |
| Correspondent | Mark Littlefield ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-14 |
| Decision Date | 1998-07-09 |
| Summary: | summary |