The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for Fetal Blood Sampling Kit Model 1560.
| Device ID | K810028 |
| 510k Number | K810028 |
| Device Name: | FETAL BLOOD SAMPLING KIT MODEL 1560 |
| Classification | Sampler, Blood, Fetal |
| Applicant | TRANSIDYNE GENERAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGW |
| CFR Regulation Number | 884.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-06 |
| Decision Date | 1981-01-16 |