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 |