Alamar Biosciences Inc. said that it has received informalindications from the staff of the FDA that additionalinformation will be necessary for the agency to fully evaluateAlamar's bacterial identification kit before it can be marketedin the U.S.

The Sacramento, Calif., company said it still expects FDA togrant 510(k) clearance for the kit, but that it will take longerthan the company's expectations, which had targeted early1993.

Alamar said it submitted a 510(k) notification for the kit lastNovember.

The company (NASDAQ:ALMRU) said it could not now predictwhen the kit would be approved.

(c) 1997 American Health Consultants. All rights reserved.

No Comments