The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Lancer Mb/cpk Isoenzyme Kit.
Device ID | K760871 |
510k Number | K760871 |
Device Name: | LANCER MB/CPK ISOENZYME KIT |
Classification | Colorimetric Method, Cpk Or Isoenzymes |
Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JHY |
CFR Regulation Number | 862.1215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-18 |
Decision Date | 1976-11-02 |