Automated blood culturing device 510(k) deadline extended to Dec. 26 -- agency letter.
This article was originally published in The Gray Sheet
AUTOMATED BLOOD CULTURING SYSTEM 510(K) DEADLINE EXTENDED TO DEC. 26, FDA says in a letter to Washington, D.C. law firm Hogan & Hartson. Responding to a request made by Hogan & Hartson attorney Howard Holstein on behalf of Organon Teknika, FDA says it is granting a 60-day grace period on the Oct. 25 deadline for 510(k) submissions. The 510(k) deadline was established in a July 27 final rule revoking the 510(k)-exempt status of the devices ("The Gray Sheet" July 31, p. 23).
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