The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for 1570 - Fetal Blood Sampling Kit.
| Device ID | K891388 |
| 510k Number | K891388 |
| Device Name: | 1570 - FETAL BLOOD SAMPLING KIT |
| Classification | Sampler, Blood, Fetal |
| 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 | HGW |
| CFR Regulation Number | 884.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-14 |
| Decision Date | 1989-03-28 |