Microbiology Devices Panel Meeting

Thursday, October 11, 2001

Premarket Approval Application: Sepsis Inc., Endotoxin Activity. An in vitro diagnostic device for the determination of endotoxin activity in human blood samples, to rule out gram negative infection.

Sepsis Inc.

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Summary of Safety and Effectiveness PMA Module #M000023/PMA   pdf

Premarket Notification Submission : An in vitro diagnostic device for detecting and measuring urinary tract infection by semiquantitative analysis of volatile compounds released from urine samples.

Osmetech plc

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

510(k) Summary   pdf