The following data is part of a premarket notification filed by Collagen Corp. with the FDA for Vitrogen Tm 100.
| Device ID | K812617 |
| 510k Number | K812617 |
| Device Name: | VITROGEN TM 100 |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | COLLAGEN CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-15 |
| Decision Date | 1981-10-02 |