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U.S. Department of Health and Human Services

510(k) Premarket Notification

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21 to 28 of 28 Results
ProductCode: JJX Applicant: ABBOTT LABORATORIES Decision Date To: 05/17/2024
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abbott axsym 3rd generation tsh assay ABBOTT LABORATORIES K981060 04/29/1998
abbott hcg serum controls ABBOTT LABORATORIES K970527 03/03/1997
axsym free triiodothyronine (free t3) ABBOTT LABORATORIES K963827 10/30/1996
imx free triiodothyronine (free t3) ABBOTT LABORATORIES K963833 10/30/1996
axsym ultrasensitive htsh ii ABBOTT LABORATORIES K952148 06/29/1995
imx ultrasensistive htsh ii ABBOTT LABORATORIES K942566 08/16/1994
axsym luteinizing hormone (lh) ABBOTT LABORATORIES K935611 06/21/1994
testpack acute hcg serum controls ABBOTT LABORATORIES K863126 09/15/1986
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