The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Fibro-tec Test Kit.
| Device ID | K791358 |
| 510k Number | K791358 |
| Device Name: | FIBRO-TEC TEST KIT |
| Classification | Fibrin Split Products |
| Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-24 |
| Decision Date | 1979-09-04 |