510(k) K023368
- Device
- TRUCATH.IP
- Applicant
- AORTECH CRITICAL CARE LTD.
- 510(k) number
- K023368
- Product code
- DFG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-28
- Date received
- 2002-10-08
- Regulation
- 866.5550
- Classification name
- Lambda, Rhodamine, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL BURNS
- Address
- Phoenix Crescent, Strathclyde Business Park Bellshill, Lanarkshire GB ML4 3NJ ML4 3NJ
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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