The following data is part of a premarket notification filed by J R Scientific with the FDA for Rpmi-1640 W/25mm Hepes Buff W/o Sod Bicar 200-2120.
Device ID | K883141 |
510k Number | K883141 |
Device Name: | RPMI-1640 W/25MM HEPES BUFF W/O SOD BICAR 200-2120 |
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 | 1988-07-26 |
Decision Date | 1988-08-15 |