ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER
FDA 510(k) clearance K944227 · decided 1995-02-03
Clearance details
- K-number
- K944227
- Device name
- ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER
- Applicant
- Medical Laboratory Automation Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-01
- Decision date
- 1995-02-03
- Days to decision
- 155 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.