EBV EA-D IGG ELISA KIT, MODEL EBG-100
FDA 510(k) clearance K021793 · decided 2002-09-27
Clearance details
- K-number
- K021793
- Device name
- EBV EA-D IGG ELISA KIT, MODEL EBG-100
- Applicant
- Pan Bio Pty. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-31
- Decision date
- 2002-09-27
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LSE
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Brisbane, Queensland, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.