The following data is part of a premarket notification filed by Medical Laboratory Automation Systems, Inc. with the FDA for Electra 1600c Automatic Coagulation Timer.
| Device ID | K931206 |
| 510k Number | K931206 |
| Device Name: | ELECTRA 1600C AUTOMATIC COAGULATION TIMER |
| Classification | Instrument, Coagulation, Automated |
| Applicant | MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville, NY 10570 |
| Contact | Joann Hanchrow |
| Correspondent | Joann Hanchrow 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 | 1993-03-10 |
| Decision Date | 1993-08-23 |