The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for 1400 Series Evidence Collection Kit.
| Device ID | K896373 |
| 510k Number | K896373 |
| Device Name: | 1400 SERIES EVIDENCE COLLECTION KIT |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | TRANSIDYNE GENERAL CORP. 3711 PLAZA DR., #4 Ann Arbor, MI 48108 |
| Contact | Margaret K Beaudet |
| Correspondent | Margaret K Beaudet TRANSIDYNE GENERAL CORP. 3711 PLAZA DR., #4 Ann Arbor, MI 48108 |
| Product Code | GIM |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1990-02-26 |