
Em Diagnostic Systems, Inc.
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EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95 is an FDA 510(k)-cleared medical device (K863738) manufactured by Em Diagnostic Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 1986. Regulation: 8.