The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Buffer, Corning Mopso.
Device ID | K790294 |
510k Number | K790294 |
Device Name: | BUFFER, CORNING MOPSO |
Classification | Fluorometric Method, Cpk Or Isoenzymes |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JHX |
CFR Regulation Number | 862.1215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-08 |
Decision Date | 1979-03-21 |