The following data is part of a premarket notification filed by J R Scientific with the FDA for Fetal Bovine Serum, Gamma Irradiated No. 110-1122.
| Device ID | K883446 |
| 510k Number | K883446 |
| Device Name: | FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122 |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | J R SCIENTIFIC ONE HARTER AVE., SUITE B P.O. BOX 1937 Woodland, CA 95695 |
| Contact | G Konish,phd |
| Correspondent | G Konish,phd J R SCIENTIFIC ONE HARTER AVE., SUITE B P.O. BOX 1937 Woodland, CA 95695 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1988-08-29 |