The following data is part of a premarket notification filed by Regency Biotech with the FDA for Fbs, Eq., Or Fetal Bovine Serum Equivalent.
| Device ID | K884031 |
| 510k Number | K884031 |
| Device Name: | FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | REGENCY BIOTECH 2469 EAST FORT UNION BLVD. SUITE 108 Salt Lake City, UT 84121 |
| Contact | R Cornelius |
| Correspondent | R Cornelius REGENCY BIOTECH 2469 EAST FORT UNION BLVD. SUITE 108 Salt Lake City, UT 84121 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-23 |
| Decision Date | 1988-10-06 |