The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Ck Monoeactif.
| Device ID | K881267 |
| 510k Number | K881267 |
| Device Name: | BIOTROL CK MONOEACTIF |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern, PA 19355 |
| Contact | Allan C Murphy |
| Correspondent | Allan C Murphy BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern, PA 19355 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-24 |
| Decision Date | 1988-05-16 |