The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Sorbitol Macconkey Agar No. 3 Cm 813.
Device ID | K872956 |
510k Number | K872956 |
Device Name: | SORBITOL MACCONKEY AGAR NO. 3 CM 813 |
Classification | Culture Media, Selective And Differential |
Applicant | OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
Contact | Ruth Kemp |
Correspondent | Ruth Kemp OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
Product Code | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-29 |
Decision Date | 1987-08-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05032384004072 | K872956 | 000 |