ELECTRA 1600C AUTOMATIC COAGULATION TIMER
FDA 510(k) clearance K931206 · decided 1993-08-23
Clearance details
- K-number
- K931206
- Device name
- ELECTRA 1600C AUTOMATIC COAGULATION TIMER
- Applicant
- Medical Laboratory Automation Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-10
- Decision date
- 1993-08-23
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- GKP
- Device class
- 2
- Regulation number
- 864.5400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Pleasantville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.