ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
FDA 510(k) clearance K926002 · decided 1993-09-23
Clearance details
- K-number
- K926002
- Device name
- ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
- Applicant
- Alamar Biosciences Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-27
- Decision date
- 1993-09-23
- Days to decision
- 300 days
- Clearance type
- Traditional
- Product code
- JSS
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.