The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Ck-mb Isoenzyme Reagent.
Device ID | K904866 |
510k Number | K904866 |
Device Name: | COULTER CK-MB ISOENZYME REAGENT |
Classification | Chromatographic Separation, Cpk Isoenzymes |
Applicant | COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
Contact | Richardson Jones |
Correspondent | Richardson Jones COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
Product Code | JHT |
CFR Regulation Number | 862.1215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-29 |
Decision Date | 1990-12-13 |