The following data is part of a premarket notification filed by Medical Laboratory Automation Systems, Inc. with the FDA for Electra 1400c Automatic Coagulation Analyzer.
| Device ID | K944227 |
| 510k Number | K944227 |
| Device Name: | ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER |
| Classification | Instrument, Coagulation, Automated |
| Applicant | MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville, NY 10570 |
| Contact | Joann H Lopez |
| Correspondent | Joann H Lopez MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville, NY 10570 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-01 |
| Decision Date | 1995-02-03 |