The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for Fetal Blood Sampling Kit #1560.
| Device ID | K831459 |
| 510k Number | K831459 |
| Device Name: | FETAL BLOOD SAMPLING KIT #1560 |
| Classification | Sampler, Blood, Fetal |
| Applicant | TRANSIDYNE GENERAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HGW |
| CFR Regulation Number | 884.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-06 |
| Decision Date | 1983-06-30 |