FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
FDA 510(k) clearance K960183 · decided 1996-06-07
Clearance details
- K-number
- K960183
- Device name
- FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
- Applicant
- Smithkline Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-16
- Decision date
- 1996-06-07
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- LYR
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.