SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
FDA 510(k) clearance K020689 · decided 2002-10-31
Clearance details
- K-number
- K020689
- Device name
- SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
- Applicant
- Midi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-04
- Decision date
- 2002-10-31
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- NJO
- Device class
- 1
- Regulation number
- 866.3370
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.