The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Mycoplasma Supplement G.
Device ID | K800253 |
510k Number | K800253 |
Device Name: | MYCOPLASMA SUPPLEMENT G |
Classification | Supplement, Culture Media |
Applicant | OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSK |
CFR Regulation Number | 866.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-06 |
Decision Date | 1980-03-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05032384011377 | K800253 | 000 |