The following data is part of a premarket notification filed by J R Scientific with the FDA for Ex-cell 300tm, Catalog # 210-3579.
| Device ID | K883631 |
| 510k Number | K883631 |
| Device Name: | EX-CELL 300TM, CATALOG # 210-3579 |
| 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 | Marilyn G Konish |
| Correspondent | Marilyn G Konish 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 | 1988-08-22 |
| Decision Date | 1988-09-07 |