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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI -- Ignore unavailable to you. Want to Upgrade?

To: Clayleas who wrote (3067)	6/12/1998 8:08:00 PM
From: jpbrody	Read Replies (1) \| Respond to of 5736

FDA clearance was given to a Colormate III. I believe this is the console device renamed TLC Bilitest presented in New Orleans. If there is another FDA approval, I am unaware of it and would appreciate you pointing it out. Here's an excerpt from the shareholder letter at Message 2101576 We are also proud to announce that the staff of the Company's new engineering facility in Spokane, Washington completed the working prototype of the new Colormate(tm)III System transcutaneous bilirubinometer with all necessary UL and FCC approvals for submission in its 510(k) application to the FDA in November 1996. The Company anticipates that its R&D effort to develop the mass manufacturing prototype of the new miniaturized Colormate III will be completed in 1997. The Company is also proud to announce that it has acquired new patents in Australia, Mexico and Taiwan during 1996. This implies that the miniaturized device was never submitted to the FDA. There is no way that they can submit data on the console device and automatically get the handheld device passed too. There may be a streamlined approach to getting modifications approved, but you definitely need to go through the FDA for approval.