
Micromedic Systems
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AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT is an FDA 510(k)-cleared medical device (K871505) manufactured by Micromedic Systems. 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 25, 1987. Regulation: 8.