The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Ck-mb Reagent.
| Device ID | K971817 |
| 510k Number | K971817 |
| Device Name: | OLYMPUS CK-MB REAGENT |
| Classification | Atp And Creatine Kinase (enzymatic), Creatine |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | JLB |
| CFR Regulation Number | 862.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-16 |
| Decision Date | 1997-06-11 |