The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for C.l.e.d. Medium.
Device ID | K832573 |
510k Number | K832573 |
Device Name: | C.L.E.D. MEDIUM |
Classification | Culture Media, Non-selective And Differential |
Applicant | ACUMEDIA MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSH |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-02 |
Decision Date | 1983-09-12 |