The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx Estradiol Mode 1 Calibrator; Abbott.
| Device ID | K032458 |
| 510k Number | K032458 |
| Device Name: | ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT |
| Classification | Calibrator, Secondary |
| Applicant | ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park, IL 60064 -6187 |
| Contact | Denise Farmer |
| Correspondent | Denise Farmer ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park, IL 60064 -6187 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-11 |
| Decision Date | 2003-10-06 |
| Summary: | summary |