|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
testpack acute hcg serum controls
|
ABBOTT LABORATORIES
|
K863126 |
09/15/1986
|
testosterone test system; calibrator; and quality control material (assayed and unassayed)
|
ABBOTT LABORATORIES
|
K120009 |
09/11/2012
|
imx ultrasensistive htsh ii
|
ABBOTT LABORATORIES
|
K942566 |
08/16/1994
|
imx free triiodothyronine (free t3)
|
ABBOTT LABORATORIES
|
K963833 |
10/30/1996
|
hemoglobin a1c, hemoglobin a1c calibrators, hemoglobin a1c controls
|
ABBOTT LABORATORIES
|
K130255 |
02/28/2014
|
hemoglobin a1c assay, hemoglobin a1c calibrators, hemoglobin a1c controls
|
ABBOTT LABORATORIES
|
K140654 |
05/22/2015
|
axsym ultrasensitive htsh ii
|
ABBOTT LABORATORIES
|
K952148 |
06/29/1995
|
axsym luteinizing hormone (lh)
|
ABBOTT LABORATORIES
|
K935611 |
06/21/1994
|
axsym free triiodothyronine (free t3)
|
ABBOTT LABORATORIES
|
K963827 |
10/30/1996
|
axsym digoxin iii
|
ABBOTT LABORATORIES
|
K061249 |
06/02/2006
|