Serim’s 510(k) Cleared Dialysis Products

February 28, 2013

Dear Dialysis Professional,

In a recent customer letter from Hach, the company states that Hach’s colorimeter based chlorine and chloramine tests must be labeled with a warning statement that the products have not been evaluated to test for chlorine or chloramines for medical applications.  Consequently, these products need to be cleared through the FDA 510(k) process in order to test for chlorine and chloramines in dialysis water treatment systems.  Until these products are cleared, Hach may not market these devices for this purpose.

Serim Research Corporation manufacturers quality dialysis products in an FDA registered facility certified to ISO 9001:2008 and ISO 13485:2003.  In response to recent customer inquiries and as part of Serim’s ongoing service and quality efforts, we have attached a list of Serim’s dialysis products that have been cleared through the 510(k) process (see below).

 

 

If Serim can be of assistance in supplying you with the appropriate cleared tests, please contact us at 1-800-542-4670.

Sincerely,

Serim Research Corporation

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