The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Immunoassay/clinical Chemistry Single Analyte Quality Control Materials (assayed) And Abbott Estradiol Calibrator.
| Device ID | K041687 |
| 510k Number | K041687 |
| Device Name: | ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT: 09VA BLDG: AP6C-2 Abbott Park, IL 60064 -3500 |
| Contact | Kent Smith |
| Correspondent | Kent Smith ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT: 09VA BLDG: AP6C-2 Abbott Park, IL 60064 -3500 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-22 |
| Decision Date | 2004-08-18 |
| Summary: | summary |