The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Creatine Kinase (ck) Isoenzyme Mb.
Device ID | K881168 |
510k Number | K881168 |
Device Name: | CREATINE KINASE (CK) ISOENZYME MB |
Classification | Chromatographic Separation, Cpk Isoenzymes |
Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Contact | Marjorie B Potts |
Correspondent | Marjorie B Potts DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Product Code | JHT |
CFR Regulation Number | 862.1215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-18 |
Decision Date | 1988-11-10 |