The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Creatine Phosphokinase(ck) Procedure.
Device ID | K863587 |
510k Number | K863587 |
Device Name: | CREATINE PHOSPHOKINASE(CK) PROCEDURE |
Classification | Nad Reduction/nadh Oxidation, Cpk Or 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 | CGS |
CFR Regulation Number | 862.1215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-15 |
Decision Date | 1986-10-03 |