The following data is part of a premarket notification filed by Medical Laboratory Automation Systems, Inc. with the FDA for Electra(r) 800 Automatic Coagulation Timer.
| Device ID | K864534 |
| 510k Number | K864534 |
| Device Name: | ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville, NY 10570 |
| Contact | John V Belliotti |
| Correspondent | John V Belliotti MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville, NY 10570 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-17 |
| Decision Date | 1987-02-06 |