LHK — Antigen, Id, Candida Albicans Class II
FDA Device Classification
Classification Details
- Product Code
- LHK
- Device Class
- Class II
- Regulation Number
- 866.3165
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K893753 | bd becton dickinson vacutainer systems preanalytic | DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST | October 16, 1989 |
| K823016 | ramco laboratories | CANDIDA DETECTION SYSTEM | December 28, 1982 |
| K812741 | nolan biological laboratories | REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS | October 23, 1981 |
| K812186 | american scientific products | CANDIDA IMMUNODIFFUSION SYSTEM | August 25, 1981 |