The following data is part of a premarket notification filed by Medical Laboratory Automation Systems, Inc. with the FDA for Electra 800 Automatic Coagulation Timer.
| Device ID | K851169 |
| 510k Number | K851169 |
| Device Name: | ELECTRA 800 AUTOMATIC COAGULATION TIMER |
| Classification | Instrument, Coagulation |
| Applicant | MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 500 NUBER AVE. Mount Vernon, NY 10550 |
| Contact | Richard E Scordato |
| Correspondent | Richard E Scordato MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 500 NUBER AVE. Mount Vernon, NY 10550 |
| Product Code | KQG |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-22 |
| Decision Date | 1985-06-24 |