
Emd Chemicals, Inc.
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TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 is an FDA 510(k)-cleared medical device (K950128) manufactured by Emd Chemicals, 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 May 14, 1995. Regulation: 8.