SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT— 510(k) K875361
Substantially EquivalentDisease Detection International, Inc.
FDA 510(k) clearance K875361 for SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT, Substantially Equivalent on 1988-05-13. Applicant: Disease Detection International, Inc..
Clearance details
- Applicant
- Disease Detection International, Inc.
- Product code
- Code LFZ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.