The following data is part of a premarket notification filed by J R Scientific with the FDA for Hanks' Balanced Salt Solution No. 210-3015.
Device ID | K882855 |
510k Number | K882855 |
Device Name: | HANKS' BALANCED SALT SOLUTION NO. 210-3015 |
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 | 1988-07-11 |
Decision Date | 1988-07-28 |