
Em Diagnostic Systems, Inc.
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CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 is an FDA 510(k)-cleared medical device (K924599) 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 October 14, 1992. Regulation: 8.