The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for Dynazyme Tm Ii Cardiak-mb.
| Device ID | K772172 |
| 510k Number | K772172 |
| Device Name: | DYNAZYME TM II CARDIAK-MB |
| Classification | U.v. Method, Cpk Isoenzymes |
| Applicant | J.T. BAKER CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHW |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-21 |
| Decision Date | 1977-12-06 |