The following data is part of a premarket notification filed by Panmed, Inc. with the FDA for Erythocyte Creatine.
| Device ID | K852767 |
| 510k Number | K852767 |
| Device Name: | ERYTHOCYTE CREATINE |
| Classification | Conversion To Creatinine, Creatine |
| Applicant | PANMED, INC. 505 WEST LOCUST Three Oaks, MI 49128 |
| Contact | Roger Vern |
| Correspondent | Roger Vern PANMED, INC. 505 WEST LOCUST Three Oaks, MI 49128 |
| Product Code | JLA |
| CFR Regulation Number | 862.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-28 |
| Decision Date | 1986-11-13 |