The following data is part of a premarket notification filed by Medical Laboratory Automation Systems, Inc. with the FDA for Thrombin Clot Time Test Procedure.
| Device ID | K923220 |
| 510k Number | K923220 |
| Device Name: | THROMBIN CLOT TIME TEST PROCEDURE |
| Classification | Test, Thrombin Time |
| 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 | GJA |
| CFR Regulation Number | 864.7875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-01 |
| Decision Date | 1992-09-29 |