
Astoria-Pacific, Inc.
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ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K is an FDA 510(k)-cleared medical device (K990957) manufactured by Astoria-Pacific, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 10, 1999. Regulation: 8.