COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2

COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 is an FDA 510(k)-cleared medical device (K901933) manufactured by Diagnostic Products Corp.. 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 June 27, 1990. Regulation: 8.