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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: JIX Applicant: JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. Decision Date To: 06/04/2024
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vitros immunodiagnostics products/ck-mb reagent pack(gem.1300)/ck-mb calibrators (gem.c300) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. K973030 09/04/1997
ektachem clinical chemistry calcium (ca) slide JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. K961226 05/07/1996
ektachem clinical chemistry slide potassium (k+) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. K961115 05/07/1996
ektachem clinical chemistry slide sodium (na+) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. K961099 05/07/1996
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