The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Hl-1, Defined Serum Free Media.
Device ID | K841993 |
510k Number | K841993 |
Device Name: | HL-1, DEFINED SERUM FREE MEDIA |
Classification | Media And Components, Synthetic Cell And Tissue Culture |
Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KIT |
CFR Regulation Number | 864.2220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-15 |
Decision Date | 1984-06-25 |