The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Cpk Color Test Kit.
Device ID | K771849 |
510k Number | K771849 |
Device Name: | CPK COLOR TEST KIT |
Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGS |
CFR Regulation Number | 862.1215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-09-28 |
Decision Date | 1977-11-03 |