Immucor Message Board - Msg: 3752680

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Biotech / Medical : Immucor

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To: technetx who wrote (38)	3/18/1998 12:26:00 PM
From: Thomas Kirwin	of 422

ABS2000 Status Report Technetx, IMHO Immucor management possesses knowledge regarding the status of their golden egg the ABS2000. The FDA has a 510(k) Status Request Program in place that allows the submitter to request a status every 30 days. Of course this information is not to be publicly disclosed as required by the FDA. Here is an excerpt from the FDA web site regarding this process. 510(k) Status Request Program Applicants may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k). Thereafter, the applicant may request status reports every 30 days following the initial status request. To obtain a 510(k) status report, the applicant should complete a status request form and fax or mail it to DSMA. Within 3 working days after a status request is received, DSMA will send the applicant a fax or letter that includes: The branch to which the 510(k) is assigned; The last action, and date of action, that ODE has taken regarding the 510(k); The position of the 510(k) in the reviewer's queue; and The average review time for the division or branch. Regards, Tom

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