The following data is part of a premarket notification filed by Medical Chemical Corporation with the FDA for Para-fix C&s Medium.
Device ID | K150887 |
510k Number | K150887 |
Device Name: | Para-Fix C&S Medium |
Classification | Culture Media, Non-propagating Transport |
Applicant | MEDICAL CHEMICAL CORPORATION 19430 VAN NESS AVE Torrance, CA 90501 -1104 |
Contact | Kris J Kontis |
Correspondent | Kris J Kontis MEDICAL CHEMICAL CORPORATION 19430 VAN NESS AVE Torrance, CA 90501 -1104 |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-02 |
Decision Date | 2015-05-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M445890240 | K150887 | 000 |
M445280505WB0 | K150887 | 000 |
M445280505REDSP02 | K150887 | 000 |
M445280505ORNG2 | K150887 | 000 |
M44528050510PCK0 | K150887 | 000 |
M4452805050 | K150887 | 000 |