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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 10 Results
ProductCode: LLL Applicant: DIAMEDIX CORP. Decision Date To: 11/28/2022
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diamedix is-ena-6 screen test system DIAMEDIX CORP. K980759 04/23/1998
is-anti-jo-1 test system DIAMEDIX CORP. K970228 04/08/1997
is-anti-scl-70 test system (720-280) DIAMEDIX CORP. K970239 04/08/1997
is-anti-sm test system DIAMEDIX CORP. K970220 04/08/1997
is-anti-sm/rnp (720-270) DIAMEDIX CORP. K970238 04/08/1997
is-anti-ssa test system DIAMEDIX CORP. K970218 04/08/1997
is-anti-ssb test system (720-260) DIAMEDIX CORP. K970237 04/08/1997
anti-jo-1 microassay DIAMEDIX CORP. K911679 09/23/1991
anti-rnp microassay DIAMEDIX CORP. K901073 03/19/1990
anti-ssa microassay and anti-ssb microassay DIAMEDIX CORP. K900241 02/02/1990